FDA Device recall Z-1044-2022
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit
- FDA Device
- Class I
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class I recall of Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit by Woodside Acquisitions, citing firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1044-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-04-09 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Woodside Acquisitions |
| Distribution | AL, GA |
Product
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Reason
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1044-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.