CLASS II ONGOING Device recall · Reported 27 Apr 2022 · FDA Enforcement Report
Flowflex Sars-CoV-2 Antigen Rapid Test (Self-Testing), CE marked recalled
Acon Biotech (Hangzhou) Co is recalling Flowflex Sars-CoV-2 Antigen Rapid Test (Self-Testing), CE marked, distributed nationwide in the US. The recall was initiated on 9 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0945-2022
- FDA event ID
- 89755
- Recalling firm
- Acon Biotech (Hangzhou) Co, Hangzhou
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2022
- FDA classified
- 15 Apr 2022
- Reported
- 27 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Jan 2022 | Recall initiated by company | |
| 15 Apr 2022 | Classified by FDA | +96 days |
| 27 Apr 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Where it was distributed
US: MD, PA International Distribution to countries of: Hungary and China.
Questions about this recall
Is Flowflex Sars-CoV-2 Antigen Rapid Test (Self-Testing), CE marked recalled?
Yes. Acon Biotech (Hangzhou) Co recalled Flowflex Sars-CoV-2 Antigen Rapid Test (Self-Testing), CE marked on 9 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0945-2022.
Why was it recalled?
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.
Which lots are affected?
Lots: COV1080201, COV1105014
Where was it sold?
US: MD, PA International Distribution to countries of: Hungary and China.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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