FDA Medical Device Recalls (openFDA)
Jiangsu Well Biotech Co.,Ltd.: Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
- Recall number
- Z-0001-2023
- Recalling firm
- Jiangsu Well Biotech Co.,Ltd.
- Product
- Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
- Status
- Open, Classified
- Initiated
- 2022-08-09
- Posted
- 2022-10-08
- Terminated
- not on file
- 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.
- Root cause
- No Marketing Application
- Action
- On 08/30/2022, Jiangsu Well Biotech Co. Ltd, notified its U.S. Distributor, DIVOC Diagnostics LLC via email with an "IMPORTANT!!! Recall Notice" and followed up with an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that Jiangsu Well Biotech is recalling the SDI LABS COVID-19 AG Rapid Test Device Cat#: CO-02 because these tests have not received FDA Emergency Use Authorization, nor have they been cleared or approved by FDA for commercial distribution in the U.S. Customers are asked to: 1. Stop using/distributing the COVID-19 Ag Rapid Test Device in their possession immediately; 2. Count the tests in their possession and write the number on the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and return the forms to Jiangsu Well Biotech via email 3. Return all unused product to Jiangsu Well Biotech 4. I the products have been further distributed, forward the recall information to all affected customers. For questions - contact Jiangsu Well Biotech Co. Ltd. via email at sales@wellbioscience.com, or to Huiying Wang, General Manager at hiuying.wang@wellbioscience.com
- Quantity
- 620,000 tests
- Distribution
- U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
- Lot, serial or model codes
- Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3014719962
- Firm city
- Changzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28