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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89028

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 04, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Migo Trading LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0421-2022
Recall number
Z-0421-2022
Initiated
November 04, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Migo Trading LLC
Quantity
200,100 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

NY