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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

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

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 E-Mail
Distribution Pattern Nationwide; Worldwide