Tuesday, January 17, 2012

American Red Cross Fined $9.6 Million for Blood-Safety Lapses AGAIN

American Red Cross Fined $9.6 Million for Blood-Safety Lapses


January 14, 2012, 5:53 PM EST


By Molly Peterson


Jan. 14 (Bloomberg) -- The American Red Cross, the biggest U.S. supplier of donated blood, was fined $9.59 million after regulators found 16 of the organization’s facilities failed to comply with blood-safety rules.


Food and Drug Administration inspectors found “significant violations” from April 2010 to October 2010, including inadequate “managerial control,” record-keeping and quality assurance, the agency said yesterday in a letter to the Washington-based organization.


The FDA didn’t find any evidence that the lapses led to any serious health consequences for blood recipients, said Mary Malarkey, head of compliance at the agency’s Center for Biologics Evaluation and Research.


“The safety of the nation’s blood supply is one of our top priorities, and we have no reason to believe that it has been compromised in any way,” Malarkey said yesterday in a phone interview. “It’s very important to note that people who need transfusions should continue to take their doctors’ advice, and we encourage people to donate blood.”


The FDA has been working “very closely” with Red Cross management “for quite some time now,” Malarkey said. “These are not current violations and we remain hopeful that their current management team will be able to deal with the situation.”


‘Corrective Steps’


The fines issued are “primarily centered on an inspection conducted 15 months ago” at the organization’s Donor & Client Support Center in Philadelphia, the Red Cross said yesterday in an e-mailed statement.


“We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters and that improvements in operations have been made,” the Red Cross said.


The organization said it is “fully committed to meeting all FDA standards, has made significant progress in working with the FDA to comply with their regulations and requirements, and continues to work on improving its performance.”


The fines were levied under a 2003 consent decree that set penalties for failing to follow U.S. standards aimed at preventing blood contamination. The FDA has cited the Red Cross 14 times since the legal agreement was reached, Malarkey said.


The agency fined the Red Cross $16 million in 2010 for mismanagement of blood products and manufacturing violations. Those lapses didn’t endanger any patients, the agency said at the time.


--Editors: Andrew Pollack, Terje Langeland


To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net


To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net




does this really surprise anyone ???


let’s look back, shall we.


Subject: FDA Fines American Red Cross $4.2 Million (BLOOD CJD) Date: September 8, 2006 at 6:04 pm PST


CJD WATCH MESSAGE BOARD TSS FDA Fines American Red Cross $4.2 Million (BLOOD CJD) Fri Sep 8, 2006 20:01 71.248.154.242


FDA Statement FOR IMMEDIATE RELEASE Statement September 8, 2006 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA


FDA Fines American Red Cross $4.2 Million for Failure to Meet Established Blood Safety Laws


The U.S. Food and Drug Administration (FDA) announced today that the American Red Cross (ARC) is being fined $4.2 million for failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products. These fines were assessed under an amended 2003 consent decree that calls for significant financial penalties when ARC fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation's blood supply.


The fines stem from a recently completed FDA review of recalls conducted by ARC between 2003 and 2005 that found these events were preventable by ARC. The violations include breaches of Good Manufacturing Practice (GMP) such as a failure to ask appropriate donor screening questions and failure to follow manufacturer test protocols. We have no evidence that these violations resulted in serious health consequences.


Because receiving blood products always carries a degree of risk, it is important that the blood industry complies with the full set of safeguards in Federal laws and FDA regulations to minimize that risk. However, any particular breach of the safeguards does not necessarily translate into unsafe blood products, because the safeguards designed to protect the blood supply are to some extent overlapping. The FDA continues to advise care providers and consumers that rigorous protections are in place and that the blood supply is safe. Patients in need of a transfusion should continue to follow the advice of their physicians. The risks of receiving a transfusion are far less than the risk of failing to receive a transfusion when blood treatment is indicated.


Improvements in donor screening procedures and the use of a variety of new tests in the last few years have made the national blood supply safer from infectious diseases and other risks than it has been at any other time. However, because there is always some degree of risk in receiving blood products, each individual safeguard is considered critical to minimizing that risk. Although the failure of an individual safeguard does not automatically translate into the release of unsafe products, it may increase the potential for risk. It is the potential risk that FDA insists the Red Cross Board of Directors prioritize and support its new management's ability to immediately address and work to improve its approach to quality.


The amended consent decree requires ARC to:


Establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; To enhance training programs; and To improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions Since entry of the 2003 consent decree and prior to this action, FDA has issued the American Red Cross seven similar letters and assessed a total of $5.7 million in penalties.


While achieving a blood supply with zero risk of transmitting infectious disease is the ultimate objective, we recognize based on the available science that this may not be realistic. Therefore, the FDA requires blood processors to adopt and strictly follow a multi-layered safety program to protect and enhance the safety of blood products at each stage of their manufacture. At the blood collection stage, these measures generally include:


Accurate and complete educational material for donors so that they can assess their risk and decline to donate if that is appropriate; Administration of donor screening questions to identify safety risks; Checking of lists to prevent use of blood from persons known to be ineligible to donate; Quality controlled infectious disease testing procedures; Inventory controls to prevent the release of units that are unsuitable; Appropriate handling and distribution of blood and blood products for patient use; and Investigation and correction of deviations from standards ARC is responsible for approximately 45% of the nation's blood supply; other independent community-based blood centers together provide another 45%, and hospitals collect most of the remaining 10%.


Blood donations are critically needed every day to save lives, and blood donation is a safe procedure. FDA encourages persons who are in good health to donate blood and to become regular blood donors.


####




Red Cross fined $4.2 mln over blood safety


By Lisa Richwine


WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe, officials said on Friday.


The fine, the largest ever levied by the Food and Drug Administration for a blood safety violation, follows a multiyear battle between the FDA and the Red Cross, which collects about 45 percent of the blood donated in the United States each year for transfusions.


The agency said it had no evidence that any blood collected by the Red Cross harmed people who got transfusions.


But FDA officials said the failure to follow multiple safeguards increased the risk that patients could receive blood tainted by an infectious disease.


"It is not acceptable that the quality systems failed in this way," Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs, told reporters.


The FDA said its investigation found that several Red Cross recalls of blood between 2003 and 2005 could have been prevented if it had taken a series of mandatory steps to ensure donations are free of HIV or other infectious agents.


One way the Red Cross erred was by failing to ask donors about travel history that could increase the chances of having malaria or the human version of mad cow disease, FDA officials said.


The problems involved 12,000 units of blood and blood components, FDA officials said. None of the units was found to be contaminated after they were recalled.


The latest fine was issued as part of a legally binding consent decree reached in 2003 in which the Red Cross promised to improve its blood safety system. Previously, the FDA had fined the organization a total of $5.7 million.


The 2003 deal revised a 1993 agreement that allowed the FDA to fine the Red Cross for blood collection lapses.


The Red Cross said it would review the FDA's letter outlining its new concerns and respond within 20 days.


"American Red Cross's senior management takes (the letter) seriously and is committed to full compliance with the amended consent decree and all applicable federal regulations," the organization said in a statement.


The FDA said the blood supply remained very safe.






TSS


----- Original Message -----


From: Terry S. Singeltary Sr.


To: Bovine Spongiform Encephalopathy


Cc: cjdvoice@yahoogroups.com ; BLOODCJD@YAHOOGROUPS.COM ; madcow@lists.iatp.org Sent: Monday, August 07, 2006 10:28 AM


Subject: [BLOODCJD] MAD COW BLOOD HUMANS RECALL (these are dime a dozen)


CJD WATCH MESSAGE BOARD TSS MAD COW BLOOD HUMANS RECALL (these are dime a dozen) Mon Aug 7, 2006 10:24 71.248.132.189


PRODUCT a) Red Blood Cells, Recall # B-1587-6; b) Cryoprecipitated AHF, Recall # B-1588-6; c) Recovered Plasma, Recal # B-1589-6 CODE a), b) and c) Unit: 2016719 RECALLING FIRM/MANUFACTURER Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION GA and Germany


______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6; b) Fresh Frozen Plasma, Recall # B-1591-6 CODE a) and b) Unit: 2443595 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 30, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX


______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6; b) Fresh Frozen Plasma, Recall # B-1593-6 CODE a) and b) Unit: 2545596 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 14, 2004 and January 3, 2005. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX


______________________________




these usa mad cow blood for humans are a dime a dozen, the come out just about every week ;






TSS


Subject: Red Cross told to fix blood collection or face charges 15 years after warnings issued, few changes made to ensure safety


Date: July 21, 2008 at 9:58 am PST


-------------------- BSE-L@LISTS.AEGEE.ORG --------------------


July 19, 2008, 5:44PM Red Cross told to fix blood collection or face charges 15 years after warnings issued, few changes made to ensure safety


By STEPHANIE STROM New York Times


For 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood. Yet, despite $21 million in fines since 2003 and repeated promises to follow procedures intended to ensure the safety of America's blood supply, it continues to fall short.


The situation has proved so frustrating that in January the commissioner of food and drugs attended a Red Cross board meeting - a first for a commissioner - and warned members that they could face criminal charges for their continued failure to bring about compliance, according to three Red Cross officials who attended the meeting. They requested anonymity because Red Cross policy prohibits public discussion of its meetings with regulators.


"If fear is a motivator, we're happy to help out in that way," said Eric M. Blumberg, deputy general counsel at the Food and Drug Administration, though he declined to confirm what the commissioner, Andrew C. von Eschenbach, said at the meeting.


Some critics, including former Red Cross executives, have even suggested breaking off the blood services operations from the rest of the organization, as the Canadian Red Cross did a decade ago.


Recipients at risk


The problems, described in more than a dozen publicly available FDA reports - some of which cite hundreds of lapses - include shortcomings in screening donors for possible exposure to diseases; failures to spend enough time swabbing arms before inserting needles; failures to test for syphilis; and failures to discard deficient blood.


In some cases, the lapses have put the recipients of blood at risk for diseases like hepatitis, malaria and syphilis.


But according to the FDA, the Red Cross has repeatedly failed to investigate the results of its mistakes, meaning there is no reliable record of whether recipients were harmed by the blood it collected.


While many Americans see the Red Cross as the ubiquitous organization that responds to disasters big and small, its disaster-relief operation, which spends $400 million to $500 million annually, is small compared with its blood business, which generated $2.1 billion in revenue in the fiscal year that ended in June 2007.


The Red Cross, which controls 43 percent of the nation's blood supply, agrees that it has had quality-control problems and is working to fix them.


Both its officials and the drug agency point out that none of the identified problems involve the most serious category of infractions. For instance, the Red Cross now does a good job of testing for HIV and hepatitis B, officials on all sides agree. And in general, Red Cross blood is regarded as some of the safest in the world.


5 million transfusions


Still, the FDA says, the problems that remain in screening donors and following protocols for collection add unnecessary risk to blood transfusions, almost 5 million of which were done in 2007, according to the National Heart, Lung and Blood Institute.


"This is a critical piece of the public health infrastructure," said Mary A. Malarkey, director of the Office of Compliance and Biologics Quality at the FDA. "I know it's difficult to get so many people trained and properly supervised, but it has to be done."


In the last week, the FDA sent the Red Cross the results of yet another recent investigation that makes Malarkey's point: From December 2006 to April 2008, the Red Cross distributed more than 200 blood products that it had already identified as problematic, according to the investigation report.


Modest improvements


After years of quiet complaints about the Red Cross' blood business, the FDA reluctantly decided to go public with its concerns in 1993, obtaining a consent decree that required the Red Cross to strengthen quality control and training and improve its ability to identify, investigate and record problems.


"It was one of the hardest things I did as commissioner," said Dr. David A. Kessler, the FDA commissioner from 1990 to 1997. He said he agonized the move would cause undue alarm.


Fifteen years later, that consent decree, toughened in 2003 to allow the FDA to impose fines for failing to properly identify, handle and report quality control problems, has produced only modest improvements, food and drug officials said.


"Leaving aside who's at fault here, it's not working," said Kessler, now a professor of pediatric medicine at the University of California, San Francisco. "Whether it's that the American Red Cross just doesn't get it, whether it's that the relationship between the regulator and regulated is beyond the point of repair is immaterial."


Kessler said Congress should intervene at this point.


Dr. Bernadine Healy, the former chief executive of the Red Cross who made repairing the organization's blood operations a paramount goal, said the best solution might be to spin off blood services.


"Two-thirds of the revenue base of the Red Cross is blood, yet the Red Cross is run by people who think of it as primarily a disaster-relief organization, relegating blood to stepchild status," Healy said.




seems vCJDonly recalls were omitted in this article ???


SNIP...


Greetings again Dr. Freas et al at FDA,


THIS was like closing the barn door after the mad cows got loose. not only the red cross, but the FDA has failed the public in protecting them from the TSE aka mad cow agent. TSE agent i.e. bse, base, cwd, scrapie, tme, and any sub strains thereof. we do not know if these strains will or have transmitted to humans as subclinical TSE or clinical disease, and we do not know if they have or will transmit second, third, forth passage via friendly fire i.e. multiple potential routes via medical, surgical, pharmaceutical etc.


Saturday, December 08, 2007


Transfusion Transmission of Human Prion Diseases




Tuesday, October 09, 2007


nvCJD TSE BLOOD UPDATE




Saturday, December 08, 2007


Transfusion Transmission of Human Prion Diseases




Saturday, January 20, 2007


Fourth case of transfusion-associated vCJD infection in the United Kingdom






vCJD case study highlights blood transfusion risk 9 Dec 2006 by Terry S. Singeltary Sr. THIS was like closing the barn door after the mad cows got loose. not only the red cross, but the FDA has failed the public in protecting them from the TSE aka mad cow agent. TSE agent ie bse, base, cwd, scrapie, tme, ... vCJD case study highlights blood transfusion risk -






Sunday, July 20, 2008


Red Cross told to fix blood collection or face charges 15 years after warnings issued, few changes made to ensure safety




TSS


-------------------- BSE-L@LISTS.AEGEE.ORG --------------------


see full text bad blood ;










Saturday, June 25, 2011


Transmissibility of BSE-L and Cattle-Adapted TME Prion Strain to Cynomolgus Macaque


"BSE-L in North America may have existed for decades"






Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME.


snip...


The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle...




2010-2011


When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.


This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle.




2011 Monday, September 26, 2011


L-BSE BASE prion and atypical sporadic CJD




Monday, June 27, 2011


Zoonotic Potential of CWD: Experimental Transmissions to Non-Human Primates




This is an interesting editorial about the Mad Cow Disease debacle, and it's ramifications that will continue to play out for decades to come ;


Monday, October 10, 2011 EFSA


Journal 2011 The European Response to BSE: A Success Story


snip...


EFSA and the European Centre for Disease Prevention and Control (ECDC) recently delivered a scientific opinion on any possible epidemiological or molecular association between TSEs in animals and humans (EFSA Panel on Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical BSE prions as the only TSE agents demonstrated to be zoonotic so far but the possibility that a small proportion of human cases so far classified as "sporadic" CJD are of zoonotic origin could not be excluded. Moreover, transmission experiments to non-human primates suggest that some TSE agents in addition to Classical BSE prions in cattle (namely L-type Atypical BSE, Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic wasting disease (CWD) agents) might have zoonotic potential.


snip...








see follow-up here about North America BSE Mad Cow TSE prion risk factors, and the ever emerging strains of Transmissible Spongiform Encephalopathy in many species here in the USA, including humans ;




Thursday, August 4, 2011


Terry Singeltary Sr. on the Creutzfeldt-Jakob Disease Public Health Crisis, Date aired: 27 Jun 2011 (SEE VIDEO)




Saturday, March 5, 2011


MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA




Tuesday, November 01, 2011


Could we face the return of CJD? Experts fear it may lie dormant in thousands




Tuesday, November 08, 2011


Can Mortality Data Provide Reliable Indicators for Creutzfeldt-Jakob Disease Surveillance? A Study in France from 2000 to 2008 Vol. 37, No. 3-4, 2011


Original Paper


Conclusions:These findings raise doubt about the possibility of a reliable CJD surveillance only based on mortality data.




Transmission of sporadic Creutzfeldt-Jakob disease by blood transfusion: risk factor or possible biases
 
 
Maria Puopolo, Anna Ladogana, Vito Vetrugno, Maurizio PocchiariArticle first published online: 7 JAN 2011


DOI: 10.1111/j.1537-2995.2010.03004.x


© 2010 American Association of Blood Banks


BACKGROUND: The occurrence of transfusion transmissions of variant Creutzfeldt-Jakob disease (CJD) cases has reawakened attention to the possible similar risk posed by other forms of CJD.


STUDY DESIGN AND METHODS: CJD with a definite or probable diagnosis (sporadic CJD, n = 741; genetic CJD, n = 175) and no-CJD patients with definite alternative diagnosis (n = 482) with available blood transfusion history were included in the study. The risk of exposure to blood transfusion occurring more than 10 years before disease onset and for some possible confounding factors was evaluated by calculating crude odds ratios (ORs). Variables with significant ORs in univariate analyses were included in multivariate logistic regression analyses.


RESULTS: In the univariate model, blood transfusion occurring more than 10 years before clinical onset is 4.1-fold more frequent in sporadic CJD than in other neurologic disorders. This significance is lost when the 10-year lag time was not considered. Multivariate analyses show that the risk of developing sporadic CJD after transfusion increases (OR, 5.05) after adjusting for possible confounding factors. Analysis conducted on patients with genetic CJD did not reveal any significant risk factor associated with transfusion.


CONCLUSION: This is the first case-control study showing a significant risk of transfusion occurring more than 10 years before clinical onset in sporadic CJD patients. It remains questionable whether the significance of these data is biologically plausible or the consequence of biases in the design of the study, but they counterbalance previous epidemiologic negative reports that might have overestimated the assessment of blood safety in sporadic CJD.
 


Thursday, August 12, 2010


USA Blood products, collected from a donor who was at risk for vCJD, were distributed July-August 2010






Sunday, August 01, 2010


Blood product, collected from a donors possibly at increased risk for vCJD only, was distributed USA JULY 2010






NOW, let’s look today ;


Wednesday, August 24, 2011


All Clinically-Relevant Blood Components Transmit Prion Disease following a Single Blood Transfusion: A Sheep Model of vCJD




Wednesday, August 24, 2011


There Is No Safe Dose of Prions




Saturday, December 3, 2011


Candidate Cell Substrates, Vaccine Production, and Transmissible Spongiform Encephalopathies


Volume 17, Number 12—December 2011






Sunday, June 26, 2011


Risk Analysis of Low-Dose Prion Exposures in Cynomolgus Macaque






Tuesday, September 14, 2010


Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)






Monday, February 7, 2011


FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???




Thursday, December 29, 2011


Aerosols An underestimated vehicle for transmission of prion diseases?


PRION www.landesbioscience.com


please see more on Aerosols and TSE prion disease here ;






NOW, what about those vCJD only recalls by FDA, let’s just take a look at the most recent, because I got tired of keeping up with the sheer volume of vCJD only recalls. let’s see what has happened so far in 2012 ;


PRODUCT


Source Plasma. Recall # B-0216-12


CODE


Units: 07KINF3436, 07KINF5486, 07KINF6442, 07KINF6927, 07KINF7851, 08KINA1752, 08KINA3645, 08KINA4233, 08KINA4920, 08KINB0194, 08KINB0669, 08KINB2027, 08KINB2573, 08KINB3415, 08KINB3697, 09KINA6864, 09KINA7406, 09KINA8424, 09KINB0489, 09KINB1076, 09KINB1907, 09KINB2500, 09KINB3375, 09KINB4335, 09KINB5012, 09KINB5897, 09KINB6857, 09KINB7567, 09KINB5820, 09KINC3232, 09KINC3617, 09KINC5027, 09KINC6038, 09KINC7881, 09KINC8444, 09KINC9495, 07KIND5142, 07KIND6161, 07KIND6664, 07KINF8412, 07KING8746, 07KING9889, 08KINA9032, 08KINA9411, 08KINB4643, 08KINB5084, 08KINB5900, 08KINB6666, 08KINB7146, 08KINB7974, 08KINB9035, 08KINB9431, 08KINC0207, 08KINC1647, 08KINC3255, 08KINC3865, 08KINC4764, 08KINC5901, 08KINC6222, 08KINC7377, 08KINC8171, 08KINC8894, 08KINC9322, 08KIND1033, 08KIND1524, 08KIND2226, 08KIND2580, 08KIND3360, 08KIND3984, 08KIND4845, 08KIND5427, 08KIND6129, 08KIND6882, 08KIND8385, 08KIND8999, 08KINE0275, 08KINE0930, 08KINE2158, 08KINE2600, 08KINE3466, 08KINE3834, 08KINE4644, 08KINE6074, 08KINE6810, 08KINE7555, 08KINE8307, 08KINE8892, 08KINE9794, 08KINF0222, 08KINF1066, 08KINF1543, 08KINF2186, 08KINF2773, 08KINF8614, 08KINF9750, 08KING0123, 08KING1511, 08KING1696, 08KING3079, 08KING4351, 09KINA0934, 09KINA1632, 09KINA2281, 09KINA3014, 09KINA5513, 09KINA6020, 08KINA1333


RECALLING FIRM/MANUFACTURER


Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by fax on April 8, 2010. Manufacturer: BioLife Plasma Services L.P., Kokomo, IN. Firm initiated recall is complete.


REASON


Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.


VOLUME OF PRODUCT IN COMMERCE


107 units


DISTRIBUTION


CA, Austria


___________________________________


PRODUCT


Recovered Plasma. Recall # B-0396-12


CODE


Unit: W141606001436


RECALLING FIRM/MANUFACTURER


Recalling Firm: Puget Sound Blood Center, Seattle, WA, by electronic mail March 21, 2008. Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm Initiated recall is complete.


REASON


Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.


VOLUME OF PRODUCT IN COMMERCE


1 unit


DISTRIBUTION


Austria ___________________________________


PRODUCT


Recovered Plasma. Recall # B-0400-12


CODE


Unit: V71842


RECALLING FIRM/MANUFACTURER


Tacoma Pierce County Blood Bank, Tacoma, WA, by electronic mail on March 17, 2008. Firm initiated recall is complete.


REASON


Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.


VOLUME OF PRODUCT IN COMMERCE


1 unit


DISTRIBUTION


Switzerland


___________________________________


END OF ENFORCEMENT REPORT FOR JANUARY 11, 2012. #




TSS


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