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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90098

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

Open FDA event record

Event summary

Timeline bucket
April 04, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
USA Medical, 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

Diagnostic Kit SARS-cCo V Antigen Rapid Test

Z-1050-2022
Recall number
Z-1050-2022
Initiated
April 04, 2022
Classification
Class II
Status
Ongoing
Recalling firm
USA Medical, LLC
Quantity
2055 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.

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

COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.

Code information

Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None

Distribution pattern

U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.