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U.S. Department of Health and Human Services

Class 1 Device Recall COVID19 Ag Rapid Test Device

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  Class 1 Device Recall COVID19 Ag Rapid Test Device see related information
Date Initiated by Firm August 09, 2022
Date Posted October 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-0001-2023
Recall Event ID 90773
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Code Information Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
Recalling Firm/
Manufacturer		 Jiangsu Well Biotech Co.,Ltd.
No 9 Changyang Rd West
Changzhou China
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 620,000 tests
Distribution U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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