FDA Device recall Z-0001-2023
Jiangsu Well Biotech Co.,Ltd
- FDA Device
- Class I
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class I recall of Jiangsu Well Biotech Co.,Ltd by Jiangsu Well Biotech, citing distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0001-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-08-09 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Jiangsu Well Biotech |
| Distribution | CA |
Product
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Reason
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Identifiers
| code_info | Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102, |
|---|
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-0001-2023%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.