Hangzhou, China
Acon Biotech (Hangzhou) Co., Ltd. recalls
1 recall recorded since 2018, most recently on 9 January 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 January 2022
- 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.
- Distribution
- US: MD, PA International Distribution to countries of: Hungary and China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0945-2022
- Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.