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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64849
Product Type Biologics
Status Ongoing
Recalling Firm Immucor Inc
City Norcross
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide; Brazil, China, Costa Rica, Germany, Hong Kong, India, Ireland, Mexico, Singapore, Taiwan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Capture-P Indicator Red Cells package 1 x 11.5 mL Lot Nos. 226192, 22613, 226194 Class III Capture-P and Capture-P Ready Screen assays, with confirmed reduced reactivity with the weak positive control, were distributed. 3 units B-1482-13