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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 65527
Product Type Biologics
Status Terminated
Recalling Firm Immucor Inc
City Norcross
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide; Worldwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Reagent Red Blood Cells N338; N339; N340; N341; R276; R277ZA; R278; CW249ZA; CW249ZB; CW250ZA; CW250ZB Class III Capture-R Ready plates, with higher rates of equivocal and unexpected positive reactions, were distributed. 11 B-2276-13