Recall Z-0421-2022
Migo Trading LLC · initiated November 4, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Codes / lots: UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023
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.
FDA-determined cause: No Marketing Application
Action taken
On November 4, 2021, Migo Trading issued URGENT MEDICAL DEVICE RECALL notices and response forms dated November 1, 2021 to customers via email. Actions to be taken by the Customer/User: - Please inspect stock and quarantine impacted product. - Please discard any available inventory in your possession or by your customer s possession. - If you have used these devices to determine your SARS-CoV-2 infection status, it is possible that your test result is incorrect. It is recommended that you obtain a confirmatory test to determine your SARS-CoV-2 infection status. - Complete and return the attached response form via email at info@migotrading.com
Details
- Recall number
- Z-0421-2022
- Initiated
- November 4, 2021
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- 200,100 units
- Distribution
- NY
- Recalling firm
- Migo Trading LLC, Dayton, NV