FLOWFLEX COVID-19 Rapid Test Recalled for Inadequate Validation
Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.
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: This is a validation-failure recall with no reported illnesses, injuries, or hospitalizations. The hazard is real (inaccurate COVID-19 test) but currently theoretical. As a risk-of-harm product with no documented harm, the score is 3 per the rubric.
Plain-English summary
Migo Trading LLC is recalling 200,100 units of the FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing). The recalled lot codes are COV1080232 (expired 05/13/2023) and COV1095004 (expired 09/03/2023), with UDI #6921756492427.
The FDA determined the devices are inconsistent with the manufacturer's Emergency Use Authorization (EUA). The product has not been authorized for emergency use by the FDA, and the test cannot be determined to be adequately validated for its stated intended use of detecting SARS-COV-2 infection.
The recalled units were distributed in New York state.
Consumers who have purchased this test should stop using it immediately. If you have already used this test to make a COVID-19 diagnosis decision, consult a healthcare provider and use an FDA-authorized diagnostic test for confirmation.
The recalled product
- Product
- FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
- Manufacturer
- Migo Trading LLC
- Affected units
- 200,100
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)
- UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023
- COV1095004 - Expiration date: 09/03/2023
Distribution
Distributed in 1 state:
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