FDA recall Z-0421-2022

Migo Trading LLC · Class II · device

Product

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.

Distribution

NY

Key facts

Status
Ongoing
Initiation date
2021-11-04
Report date
2022-01-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dayton, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0421-2022