Recall Z-0071-2023 ยท JSM Culture Media, Non-Propagating Transport
American Contract Systems, Inc.
COVID Test Kit Nonsterile
| Date | Oct 8, 2022 (initiated Aug 12, 2022) |
| Status | Open, Classified |
| Reason | Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device. |
| Root cause | No Marketing Application |
| Action | A customer letter dated 08/12/2022 was sent on or around 08/15/2022 to the single impacted consignee. The customer is instructed that the product cannot be used in association with SARS-CoV-2 or COVID-19 testing but instead only for general use of specimen collection. The product is to be relabeled in accordance with the recall communication letter. A Field Action Response Form is to be completed and returned to angela.bunn@owens-minor.com. A second customer letter dated September 8, 2022 was sent on or around the same day to notify the consignee that 2 lots listed in this event cannot be rel |
| Quantity | 39,575 kits |
| Distribution | Distribution to one customer in PA only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.