Migo Trading LLC recalls FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

Recall date

November 4, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0421-2022

FDA classification

Class II

Brand / firm

Migo Trading LLC

Sold / distributed

NY

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test