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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
State
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

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
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