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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Capture-R Ready Indicator Red Cells
Recall Number B-2203-12
Classification Class III
Code Info Lot/Serial Number 221812
Product Distributed Qty 747 units
Reason For Recall Capture-R Ready Indicator Cells, with a rate of reported events for equivocal and unexpected positive reactions significantly higher than other lots, were distributed.

Event Detail

Event Id 61882
Product Type Biologics
Status Ongoing
Recalling Firm Immucor Inc
City Norcross
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US/Nationwide; Canada, China, Denmark, India, Israel, Japan, Philippines, & Sweden