FDA recall Z-0945-2022

Acon Biotech (Hangzhou) Co., Ltd. · Class II · device

Product

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

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.

Distribution

US: MD, PA International Distribution to countries of: Hungary and China.

Key facts

Status: Ongoing
Initiation date: 2022-01-09
Report date: 2022-04-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hangzhou, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2022