Data Foundry

Medical device recalls 2013

HSV 2 Primers — Class II medical device recall Z-2085-2013

Terminated recall by Life Technologies Corporation, reported 2013-09-04, distributed nationwide. Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

Recall numberZ-2085-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmLife Technologies Corporation, Frederick, MD, United States
Recall initiated2013-05-13
Classified2013-08-26
Reported by FDA2013-09-04
Terminated2013-08-28
DistributedNationwide (US)
Quantity15 kits
Lot numbers1312093, 1368760
Model numbers18081020

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2085-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.