biokitHSV-2 Rapid Test, REF: 300028001
- Recall Initiated
- September 28, 2022
- Posted
- January 26, 2023
- Recall Number
- Z-1021-2023
- Quantity
- 2,393
Reason for Recall
HSV-2 rapid test may report false positive results.
Distribution
US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Lot / Code Info
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
Root 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.