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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90324

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 02, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
American Contract Systems, Inc.

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

2 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 2

Clean Catch Urine Kit NS 178489, AHMU58A

Z-1276-2022
Recall number
Z-1276-2022
Initiated
May 02, 2022
Classification
Class I
Status
Ongoing
Quantity
274,400 kits total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected products were assembled off-site by individuals who may not have been properly trained.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected products were assembled off-site by individuals who may not have been properly trained.

Code information

UDI-DI: 00191072120557 Lots 891211, 737211, 699211, 986221

Distribution pattern

US distribution in the state of Minnesota.

device · product 2 of 2

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Z-1277-2022
Recall number
Z-1277-2022
Initiated
May 02, 2022
Classification
Class I
Status
Ongoing
Quantity
274,400 kits total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected products were assembled off-site by individuals who may not have been properly trained.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected products were assembled off-site by individuals who may not have been properly trained.

Code information

UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221

Distribution pattern

US distribution in the state of Minnesota.