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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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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
Distribution Pattern US/Nationwide; Canada, China, Denmark, India, Israel, Japan, Philippines, & Sweden

Product Detail

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