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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80861

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

Open FDA event record

Event summary

Timeline bucket
September 30, 2017
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Ameditech 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

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

Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process-is provided in the package labeling.

Z-0270-2019
Recall number
Z-0270-2019
Initiated
September 30, 2017
Classification
Class III
Status
Terminated
Recalling firm
Ameditech Inc
Quantity
40 kit boxes (1000 units)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was released to market without the adulteration strip included in the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was released to market without the adulteration strip included in the product.

Code information

Part Number: DS84S625, Lot Number: 174886 (US distribution only)

Distribution pattern

US in the state of California