Recall Z-1021-2023 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Biokit, S.A.
biokitHSV-2 Rapid Test, REF: 300028001
| Date | Jan 26, 2023 (initiated Sep 28, 2022) |
| Status | Open, Classified |
| 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 |
| Quantity | 2,393 |
| Distribution | US Nationwide distribution in the states of NY, CA, IN, NC, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983886 | POCKIT HSV 2 RAPID TEST Diagnology , Ltd., Aug 19, 1999 |