Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit — Class I medical device recall Z-1044-2022
Ongoing recall by Woodside Acquisitions Inc., reported 2022-05-18, distributed in AL, GA. Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United S
| Recall number | Z-1044-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Woodside Acquisitions Inc., tyrone, PA, United States |
| Recall initiated | 2022-04-09 |
| Classified | 2022-05-12 |
| Reported by FDA | 2022-05-18 |
| Distributed | AL, GA |
| Quantity | 34,240 units |
Product
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Reason for recall
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
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-1044-2022. 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.