Recall Z-0421-2022— Migo Trading LLC
Class II · Ongoing
Class II FDA medical device recall by Migo Trading LLC, initiated 2021-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test. Reason: Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use..
- Recalling firm
- Migo Trading LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-04
- Firm location
- Dayton, NV, United States
Product description
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Reason for recall
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.