Recall Z-1021-2023
Biokit, S.A. · initiated September 28, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
biokitHSV-2 Rapid Test, REF: 300028001
Codes / 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
Reason for recall
HSV-2 rapid test may report false positive results.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1021-2023
- Initiated
- September 28, 2022
- Posted by FDA
- January 26, 2023
- Product code
- LGC – Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- Quantity
- 2,393
- Distribution
- US Nationwide distribution in the states of NY, CA, IN, NC, VA.
- Recalling firm
- Biokit, S.A., Llica D'Amunt, Barcelona