Home / Recalls / Biokit, S.A. / Z-1021-2023

Z-1021-2023 Class II Ongoing

Recalled by Biokit, S.A. — Llica D'Amunt, N/A

Recall Details

Product Type: Devices
Report Date: February 1, 2023
Initiation Date: September 28, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,393

Product Description

biokitHSV-2 Rapid Test, REF: 300028001

Reason for Recall

HSV-2 rapid test may report false positive results.

Distribution Pattern

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

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