Class 2 Device Recall Flowflex SARSCoV2 Antigen Rapid Test (SelfTesting), CE marked

• Date Initiated by Firm: January 09, 2022
• Create Date: April 15, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0945-2022
• Recall Event ID: 89755
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
• Code Information: Lots: COV1080201, COV1105014
• FEI Number: 3002829675
• Recalling Firm/ Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.; 398 Tianmushan Road; Hangzhou China
• For Additional Information Contact: 011 86 858 200
• Manufacturer Reason for Recall: Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.
• FDA Determined Cause: No Marketing Application
• Action: On 04/04/22, recall notices were sent to distributor customers who were asked to do the following: If you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this correction notification letter. This correction should be carried out to the consumer/user level in U.S. Complete and return the response form to the recalling firm. Customers with additional questions were encouraged to contact Denice Dong, Denice.Dong@aconlab.com.cn Additional instructions in a press release were provided to address affected non-EUA devices, of unknown quantity, that may have entered the U.S. market. It is recommended to stop use and dispose of affected devices in the U.S. market: https://www.aconlabs.com/news/
• Quantity in Commerce: 303,760
• Distribution: US: MD, PA International Distribution to countries of: Hungary and China.
• 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.