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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68229

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

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Event summary

Timeline bucket
April 17, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Gen-Probe 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

APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

Z-1793-2014
Recall number
Z-1793-2014
Initiated
April 17, 2014
Classification
Class III
Status
Terminated
Recalling firm
Gen-Probe Inc
Quantity
4,740 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."

Code information

Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB).