Class II, Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA
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Event Detail
Event ID 61992
Product Type Biologics
Status Terminated
Recalling Firm Blood Assurance Inc
City Chattanooga
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of
Consignee or Public FAX
Distribution Pattern TN, GA, NY
Product Detail
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number
Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2009-12
Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A;
W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B;
W043211025338-B Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 6 units
B-2010-12
Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2011-12
Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572;
W043210075817 Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 4 units
B-2012-12
Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2013-12
Blood and Blood Products for Reprocessing V89413 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2014-12
Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-2015-12
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Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance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”
Friday, June 29, 2012
Highly Efficient Prion Transmission by Blood Transfusion
Sunday, June 3, 2012
A new neurological disease in primates inoculated with prion-infected blood
or blood components
Wednesday, June 27, 2012
First US BSE Case Since 2006 Underscores Need for Vigilance
Neurology Today 21 June 2012
Tuesday, June 26, 2012
Creutzfeldt Jakob Disease Human TSE report update North America, Canada,
Mexico, and USDA PRION UNIT as of May 18, 2012
type determination pending Creutzfeldt Jakob Disease (tdpCJD), is on the
rise in Canada and the USA
Wednesday, April 25, 2012
USA MAD COW DISEASE AND CJD THERE FROM SINGELTARY ET AL 1999 – 2012
TSS
posted by Terry S. Singeltary Sr. | 3:22 PM
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