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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 61861
Product Type Biologics
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics Inc.
City Berkeley
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Product was released for distribution in US and Internationally. The firm stated that National Competent Authorities notified in affected countries: Brazil, Thailand, and South Africa.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Siemens brand Trugene HIV-1, Genotyping Kit, Box 1 and Box 2, Catalog Numbers: 10336823 10336826; Product is manufactured and distributed by Siemens Healthcare Diagnostics Inc., Berkeley, CA Lot Numbers: U080A1, U080A2 Class II Trugene HIV-1 Genotype kits, not meeting current performance claims due to variation during manufacture, were distributed. 2 lots B-2263-12
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