Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain biokitHSV-2 Rapid Test, REF: 300028001 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
biokitHSV-2 Rapid Test, REF: 300028001
Brand
Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain
Lot Codes / Batch 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
Products Sold
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
Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain is recalling biokitHSV-2 Rapid Test, REF: 300028001 due to HSV-2 rapid test may report false positive results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
HSV-2 rapid test may report false positive results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026