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Open, Classified

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

FDA Recall Z-0421-2022 · Posted None

Recalling FirmMigo Trading LLC
Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2021-11-04
Product Quantity200,100 units

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.

Firm Action

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 [email protected]

Root Cause

No Marketing Application

Distribution Pattern

NY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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