Health Canada — Medical Devices · Canada · 2015-03-05 · Type III
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Reported risk: Immucor has indicated that additional testing of Cell II (Donor C5716) has determined that the Donor is LE(B) negative, instead of LE(B) positive as indicated on the master list included with the product. Therefore, Panoscreen I and II (Lot 01888) does not include a LE(B) positive red cell. This carries a risk for Anti-LE(B) to go undetected.
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