Clip COVID Rapid Antigen Test Kit — Class II medical device recall Z-0080-2023
Ongoing recall by LUMINOSTICS, INC dba CLIP HEALTH, reported 2022-10-19, distributed nationwide. COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FD
| Recall number | Z-0080-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUMINOSTICS, INC dba CLIP HEALTH, Fremont, CA, United States |
| Recall initiated | 2022-09-02 |
| Classified | 2022-10-12 |
| Reported by FDA | 2022-10-19 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| Lot numbers | CC-10094-A, CC-10115-A, CC-10123-A, CC-10129-A, CC-10136-A, CC-10144-A, CC-10148-A, CC-10166-A, CC-10168-A, CC-10168-B, CC-10189-A, CC-10193-A, CC-10300-A, CC-10328-A, CC-10329-A, CC-10330-A, CC-10361-A, CC-10364-A, CC-10365-A, CC-10368-A, CC-10369-A, CC-10395-A, CC-10396-A, CC-10397-A, CC-10398-A, CC-10399-A, CC-10439-A, CC-10440-A, CC-10440-B, CC-10441-A, CC-10441-B, CC-10609-A, CC-10609-B, CC-10611-A, CC-10613-A, CC-10615-A, CC-10654-A, CC-10667-A, CC-10710-A, CC-10710-B and 16 more |
| Model numbers | MDL002 |
Product
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Reason for recall
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
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-0080-2023. 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.