COVID Test Kit Nonsterile — Class II medical device recall Z-0071-2023
Ongoing recall by American Contract Systems, Inc., reported 2022-10-19. Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
| Recall number | Z-0071-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems, Inc., Bloomington, MN, United States |
| Recall initiated | 2022-08-12 |
| Classified | 2022-10-08 |
| Reported by FDA | 2022-10-19 |
| Quantity | 39,575 kits |
| Reason classes | labeling |
| Lot numbers | 868221, 980221 |
| Expiration dates | 2023-01-20, 2023-01-25, 2023-05-31 |
Product
COVID Test Kit Nonsterile
Reason for recall
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0071-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.