Z-0421-2022Class II

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

Name: Z-0421-2022 FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Creator: Migo Trading LLC
Published: 2021-11-04
License: https://open.fda.gov/license/

Migo Trading LLC / initiated 2021-11-04 / Open, Classified

FDA source

Migo Trading LLC began a recall of FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test on 2021-11-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0421-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-04
Posted: 2021-12-27
Recalling firm: Migo Trading LLC
Product: FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Product code: QKP Coronavirus Antigen Detection Test System.
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 root cause: No Marketing Application
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]
Quantity in commerce: 200,100 units
Distribution: NY
Product codes and lots: UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0421-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0421-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-27

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)