Jiangsu Well Biotech Co — Class I medical device recall Z-0001-2023
Ongoing recall by Jiangsu Well Biotech Co.,Ltd., reported 2022-10-19, distributed in CA. Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Marke
| Recall number | Z-0001-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jiangsu Well Biotech Co.,Ltd., Changzhou, N/A, China |
| Recall initiated | 2022-08-09 |
| Classified | 2022-10-07 |
| Reported by FDA | 2022-10-19 |
| Distributed | CA |
| Quantity | 620,000 tests |
| Lot numbers | 202107192, 202108231, 202109231, 202110111, 202111082, 202201102 |
| Model numbers | CO-02 |
Product
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Reason for recall
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
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-0001-2023. 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.