Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
- Recall Initiated
- August 9, 2022
- Posted
- October 8, 2022
- Recall Number
- Z-0001-2023
- Quantity
- 620,000 tests
- Firm Location
- West Changzhou, China
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.
Distribution
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Lot / Code Info
Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
Root Cause
No Marketing Application
Action Taken
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