Medical Device Recall: Z-0001-2023

FDA Recalls dataset · Firm: Jiangsu Well Biotech Co., Ltd. No · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2022-08-09 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2023.

Recall Res Number
Z-0001-2023
Recalling Firm / Manufacturer
Jiangsu Well Biotech Co., Ltd. No
FEI Number
3014719962
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2022-08-09
Date Posted
2022-10-08
Date Terminated
N/A
Product Code
QKP
Event Number
90773
Product Quantity
620,000 tests
Product Description 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.
Action Details 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
Distribution Pattern U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Code Information / Serial Numbers Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,

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