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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description Blood Grouping Reagent, Anti-S (Monoclonal)
Recall Number B-0064-14
Classification Class III
Code Info 822304001; 8244076001
Product Distributed Qty 2 vials
Reason For Recall Seraclone Anti-S with a reactivity decrease after approximately 12 months, was distributed.

Event Detail

Event Id 66022
Product Type Biologics
Status Terminated
Recalling Firm Bio-Rad Medical Diagnostics GmbH
City Dreieich
Country DE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Multiple U.S. States