Biokit, S.A.: Medical Device Recall in 2023 - (Recall #: Z-1021-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

biokitHSV-2 Rapid Test, REF: 300028001

Product Classification:

Class II

Date Initiated: September 28, 2022

Date Posted: February 1, 2023

Recall Number: Z-1021-2023

Event ID: 91384

Reason for Recall:

HSV-2 rapid test may report false positive results.

Status: Ongoing

Product Quantity: 2,393

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.

Voluntary or Mandated:

Voluntary: Firm initiated