Device product

biokitHSV-2 Rapid Test, REF: 300028001

Z-1021-2023

September 28, 2022

Class II

Product summary

Firm: Biokit, S.A.
Event: Event 91384
Status: Ongoing
Classification: Class II
Quantity: 2,393
Official record key: device-enforcement:Z-1021-2023

Official wording

Reason: HSV-2 rapid test may report false positive results.

Code information: UDI-DI/Lots - Expiration Dates: 08426951056439/ B34243 - 2022-09-30, B34309 - 2022-11-30, B34463 - 2022-11-30, B34465 - 2023-02-28, B35052 - 2023-05-31, B35188 - 2023-07-31, B35398 - 2023-10-31

Distribution pattern: US Nationwide distribution in the states of NY, CA, IN, NC, VA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

HSV-2 rapid test may report false positive results.