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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Human Immunodeficiency Virus Type 1 and/or HCV and/or HBV (Nucleic Acid Pooled Testing/Syn)
Recall Number B-0636-14
Classification Class III
Code Info 624104; 614564
Product Distributed Qty 2 kits (Master Lot 624104) and 5 kits (Master Lot 614564)
Reason For Recall In-vitro diagnostics, with mixed master lots, were distributed.

Event Detail

Event Id 67944
Product Type Biologics
Status Terminated
Recalling Firm Gen-Probe Inc
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern California