Exact FDA event identifier

Event 89975

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

Open FDA event record

Event summary

Timeline bucket: March 04, 2022
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: SML Distribution, 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

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Z-0944-2022

Recall number: Z-0944-2022
Initiated: March 04, 2022
Classification: Class I
Status: Ongoing
Recalling firm: SML Distribution, LLC
Quantity: 209,450 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

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

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

Code information

All lots: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q

Distribution pattern

US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.