biokitHSV-2 Rapid Test, REF: 300028001
FDA device recall Z-1021-2023 · posted 2023-01-26 · Open, Classified
Recall details
- Recalling firm
- Biokit, S.A.
- Reason for recall
- HSV-2 rapid test may report false positive results.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LGC
- Quantity affected
- 2,393
- Distribution
- US Nationwide distribution in the states of NY, CA, IN, NC, VA.
- Date initiated
- 2022-09-28
- Date posted
- 2023-01-26
- Location
- Llica D'Amunt, Barcelona, Spain
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POCKIT HSV 2 RAPID TEST (K983886) | Diagnology , Ltd. | 1999-08-19 |