Jiangsu Well Biotech Co., Ltd. No Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Brand
Jiangsu Well Biotech Co., Ltd. No
Lot Codes / Batch Numbers
Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102
Products Sold
Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
Jiangsu Well Biotech Co., Ltd. No is recalling Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 due to Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026