PlainRecalls
FDA Devices Moderate Class II 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.

Reported: September 4, 2013 Initiated: May 13, 2013 #Z-2085-2013

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.

Reason for Recall

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

Details

Units Affected
15 kits
Distribution
USA Nationwide Distribution in the states of DE, IA, MN, and NC.
Location
Frederick, MD

Frequently Asked Questions

What product was recalled?
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.. Recalled by Life Technologies Corporation. Units affected: 15 kits.
Why was this product recalled?
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 4, 2013. Severity: Moderate. Recall number: Z-2085-2013.