Z-0945-2022Class II

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

Name: Z-0945-2022 Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Creator: Acon Biotech (Hangzhou) Co., Ltd.
Published: 2022-01-09
License: https://open.fda.gov/license/

Acon Biotech (Hangzhou) Co., Ltd. / initiated 2022-01-09 / Open, Classified

FDA source

Acon Biotech (Hangzhou) Co., Ltd. began a recall of Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked on 2022-01-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0945-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-09
Posted: 2022-04-15
Recalling firm: Acon Biotech (Hangzhou) Co., Ltd.
Product: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Product code: QKP Coronavirus Antigen Detection Test System.
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 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, [email protected] 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.
Product codes and lots: Lots: COV1080201, COV1105014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0945-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0945-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-15

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)