Device 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.
Z-2085-2013
Product summary
- Event
- Event 65770
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-2085-2013
Official wording
Reason: Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
Code information: Catalog #18081020, Lot #1368760 & Lot #1312093
Distribution pattern: USA Nationwide Distribution in the states of DE, IA, MN, and NC.
Derived failure modes
-
Unknown
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.