FDA Medical Device Recalls (openFDA)
Acon Biotech (Hangzhou) Co., Ltd.: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
- Recall number
- Z-0945-2022
- Recalling firm
- Acon Biotech (Hangzhou) Co., Ltd.
- Product
- Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
- Status
- Open, Classified
- Initiated
- 2022-01-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 303,760
- Distribution
- US: MD, PA International Distribution to countries of: Hungary and China.
- Lot, serial or model codes
- Lots: COV1080201, COV1105014
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3002829675
- Firm city
- Hangzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28