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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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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
Distribution Pattern Multiple U.S. States

Product Detail

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