FLOWFLEX SARS-COV-2 Antigen Rapid Test recall
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Why was FLOWFLEX SARS-COV-2 Antigen Rapid Test recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023
- Product
- FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
- Recalling firm
- Migo Trading LLC
- Quantity
- 200,100 units
- Distribution
- NY
- Recall date
- January 5, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)