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Recall of Capture Platelets, Capture-P Ready-Screen test kits

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DATE RECALL INITIATED:

August 11, 2003

LOT NUMBERS / EXPIRATION DATES:

30895   8/22/2003
32937   9/5/2003

MANUFACTURER:

Immucor, Inc.
Norcross, GA

REASON:

Capture-P Ready-Screen test kits, lots 30895 and/or 32937 have been packaged with a Reactivity List Lot A29 & A2901 that has a typographical error for the HLA-B type of Plt1, P0141. The well is incorrectly listed as B4. The correct type is B27, B44. Consignees were asked to replace the Reactivity List provided in their kit with the corrected Reactivity List.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

Updated September 25, 2003
 
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