SARS CoV 2 rapid antigen test kits packaged under the following… — Class I medical device recall Z-1401-2022
Ongoing recall by North American Diagnostics, reported 2022-08-10, distributed nationwide. Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in th
| Recall number | Z-1401-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | North American Diagnostics, Holly Hill, FL, United States |
| Recall initiated | 2022-06-15 |
| Classified | 2022-07-29 |
| Reported by FDA | 2022-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BD, CA |
| Quantity | 122,366 units |
Product
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
Reason for recall
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
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-1401-2022. 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.