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Terminated

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.

FDA Recall Z-2085-2013 · Posted 2013-08-26

Recall StatusTerminated
Product CodeNYQ
Date Initiated2013-05-13
Date Terminated2013-08-28
Product Quantity15 kits

Reason for Recall

Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

Firm Action

Life Technologices sent an Urgent Product Recall letter dated May 13, 2013 by certified mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use and dispose all affected units. Customers were advised to complete the Customer Response Sheet included for product/quantities consumed, and send e-mail to [email protected]. For questions about the details of this product issue, were instructed to contact Technical Support at 800-955-6288 option 4.

Root Cause

Process design

Distribution Pattern

USA Nationwide Distribution in the states of DE, IA, MN, and NC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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