FDA Medical Device Recalls (openFDA)
Biokit, S.A.: biokitHSV-2 Rapid Test, REF: 300028001
- Recall number
- Z-1021-2023
- Recalling firm
- Biokit, S.A.
- Product
- biokitHSV-2 Rapid Test, REF: 300028001
- Status
- Open, Classified
- Initiated
- 2022-09-28
- Posted
- 2023-01-26
- Terminated
- not on file
- Reason
- HSV-2 rapid test may report false positive results.
- 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 oem-complaints@werfen.com, 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
- 2,393
- Distribution
- US Nationwide distribution in the states of NY, CA, IN, NC, VA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K983886"]
- PMA numbers
- not on file
- Product code
- LGC
- Firm FEI
- 3002806557
- Firm city
- Llica D'Amunt
- Firm state
- Barcelona
- Firm country
- Spain
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28