FDA Switzerland Reason For Recall Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed 2014-05-16
Reason For Recall | Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. |
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Voluntary / Mandated | Voluntary: Firm Initiated |
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Recall Initiation Date | 2014-05-16 |
Initial Firm Notification of Consignee or Public | |
Distribution Pattern | Switzerland |
Biologics | Red Blood Cells Leukocytes Reduced | W089813410351; | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Inova Health Care Services, Inova Blood Donor Services |
Biologics | Blood and Blood Products for Reprocessing | W089813410351; | Class III | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Inova Health Care Services, Inova Blood Donor Services |
Biologics | Cryoprecipitated AHF | W089813410351; | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Inova Health Care Services, Inova Blood Donor Services |
Biologics | Red Blood Cells Leukocytes Reduced | W088414515528; W088414516606; | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Blood Bank Of Hawaii |
Class II, Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA
Enforcement Report
http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html
Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”
IN SHORT ;
“However, based on animal studies, as well as on FDA risk assessments, the possibility of vCJD transmission by a U.S.-licensed plasma derivative, while extremely small, cannot be absolutely ruled out. For these reasons, the recommendations for labeling for plasma derivatives will include mention of vCJD for the first time, and the potential risk for its transmission. The recommended elements of the warning label for CJD are unchanged and continue to describe its transmission as a theoretical risk, given that there is no confirmed evidence that CJD is transmitted by blood (Refs. 4-7).“
IN FULL, as follows ;
Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”
http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html
Friday, June 29, 2012
Highly Efficient Prion Transmission by Blood Transfusion
http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html
Sunday, June 3, 2012
A new neurological disease in primates inoculated with prion-infected blood or blood components
http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html
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