Acon Biotech Flowflex COVID-19 Rapid Test Recalled for Inaccurate Results
Acon Biotech is recalling Flowflex SARS-CoV-2 Antigen Rapid Tests because the non-EUA authorized kits may produce inaccurate results, including false negatives or false positives.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device with accuracy defects that could lead to incorrect test results. Although no illnesses or injuries have been reported, false test results present a risk of harm to consumers who may make incorrect healthcare decisions based on test performance.
Plain-English summary
Acon Biotech (Hangzhou) Co., Ltd. is recalling the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), a COVID-19 rapid diagnostic test kit that carries a CE mark but lacks FDA Emergency Use Authorization.
The recall affects approximately 303,760 test kits distributed in the United States (Maryland and Pennsylvania), as well as Hungary and China. The affected lot numbers are COV1080201 and COV1105014.
The kits are being recalled because use may lead to inaccurate test results, including false negative results (failing to detect COVID-19 when present) or false positive results (incorrectly indicating COVID-19 is present when it is not). These inaccuracies could lead consumers to make incorrect healthcare decisions.
Consumers who have purchased or received these test kits should not use them. Those with questions or concerns should contact their healthcare provider.
The recalled product
- Product
- Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- Affected units
- 303,760
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: COV1080201
- COV1105014
Distribution
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