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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77702

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

Open FDA event record

Event summary

Timeline bucket
June 26, 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

Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine

Z-3084-2017
Recall number
Z-3084-2017
Initiated
June 26, 2017
Classification
Class III
Status
Terminated
Recalling firm
Ameditech Inc
Quantity
263Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

Code information

P/N IS10-DX; Lot No. U0731

Distribution pattern

Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX