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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70008

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

Open FDA event record

Event summary

Timeline bucket
November 21, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Express Diagnostics Int'l., 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

DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.

Z-1033-2015
Recall number
Z-1033-2015
Initiated
November 21, 2014
Classification
Class II
Status
Terminated
Quantity
5,050

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results.

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

This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results.

Code information

PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.

Distribution pattern

Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.