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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
Recall Number Z-2085-2013
Classification Class II
Code Info Catalog #18081020, Lot #1368760 & Lot #1312093
Product Distributed Qty 15 kits
Reason For Recall Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

Event Detail

Event Id 65770
Product Type Devices
Status Terminated
Recalling Firm Life Technologies Corporation
City Frederick
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution in the states of DE, IA, MN, and NC.