Recall Z-1277-2022 ยท JSM Culture Media, Non-Propagating Transport
American Contract Systems, Inc.
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
| Date | Jul 1, 2022 (initiated May 2, 2022) |
| Status | Open, Classified |
| Reason | Affected products were assembled off-site by individuals who may not have been properly trained. |
| Root cause | Process control |
| Action | On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits. |
| Quantity | 274,400 kits total |
| Distribution | US distribution in the state of Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.