Z-1021-2023Class II

biokitHSV-2 Rapid Test, REF: 300028001

Name: Z-1021-2023 biokitHSV-2 Rapid Test, REF: 300028001
Creator: Biokit, S.A.
Published: 2022-09-28
License: https://open.fda.gov/license/

Biokit, S.A. / initiated 2022-09-28 / Open, Classified / root cause: manufacturing process

FDA source

Biokit, S.A. began a recall of biokitHSV-2 Rapid Test, REF: 300028001 on 2022-09-28. FDA classified it as Class II and gives the reason as "HSV-2 rapid test may report false positive results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1021-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-28
Posted: 2023-01-26
Recalling firm: Biokit, S.A.
Product: biokitHSV-2 Rapid Test, REF: 300028001
Product code: LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Reason for recall: HSV-2 rapid test may report false positive results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 9/28/22, Werfen Field Action notices were emailed to customers who were asked to 1) Stop using and discard affected kits, 2) Complete and return the tracking form provided with the notice to [email protected], 3) Forward the notice to all affected facilities. On 2/10/23, Werfen Field Action notices were emailed to additional customers informing them of an additional affected lot. On 3/13/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot. On 4/11/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot.
Quantity in commerce: 2,393
Distribution: US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1021-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1021-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-26

Product code LGC

K983886Class IIPockit Hsv 2 Rapid TestDiagnology , Ltd. / cleared 1999-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)