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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Flowflex SARSCoV2 Antigen Rapid Test (SelfTesting), CE marked see related information
Date Initiated by Firm January 09, 2022
Create Date April 15, 2022
Recall Status1 Open3, 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
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 2		 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.
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