biokitHSV-2 Rapid Test, REF: 300028001 recallZ-1021-2023 · Biokit, S.A. · initiated Sep 28, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biokit, S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
HSV-2 rapid test may report false positive results.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1021-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 28, 2022
- Posted by the FDA
- Jan 26, 2023
- Recalling firm
- Biokit, S.A.
- Quantity
- 2,393
- Product code
- LGC
- FDA submissions
- K983886
- Distribution
- US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Product description
biokitHSV-2 Rapid Test, REF: 300028001
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- biokitHSV-2 300028001Biokit, S.A. · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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