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Recall Observatory FDA recall evidence

Device product

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

Z-0421-2022

November 04, 2021

Class II

Product summary

Firm
Migo Trading LLC
Event
Event 89028
Status
Ongoing
Classification
Class II
Quantity
200,100 units
Official record key
device-enforcement:Z-0421-2022

Official wording

Reason: 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.

Code information: UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023

Distribution pattern: NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.