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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description 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
Recall Number B-2263-12
Classification Class II
Code Info Lot Numbers: U080A1, U080A2
Product Distributed Qty 2 lots
Reason For Recall Trugene HIV-1 Genotype kits, not meeting current performance claims due to variation during manufacture, were distributed.

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.