Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen… — Class I medical device recall Z-0929-2023
Ongoing recall by Universal Meditech Inc., reported 2023-02-08, distributed nationwide. Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Aut
| Recall number | Z-0929-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Universal Meditech Inc., Fresno, CA, United States |
| Recall initiated | 2022-11-28 |
| Classified | 2023-01-27 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 56,300 kits |
| Lot numbers | UL-AG-2110-03-Q, UL-AG-2110-04-Q, UL-AG-2110-05-Q, UL-AG-2111-01-Q, UL-AG-2111-02-Q, UL-AG-2112-02-Q |
| Model numbers | 550-10 |
Product
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Reason for recall
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
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-0929-2023. 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.