APTIMA Urine Collection Kit — Class III medical device recall Z-1793-2014

Terminated recall by Gen-Probe Inc, reported 2014-06-25, distributed nationwide. Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The o

Recall number	`Z-1793-2014`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Gen-Probe Inc, San Diego, CA, United States
Recall initiated	2014-04-17
Classified	2014-06-13
Reported by FDA	2014-06-25
Terminated	2014-08-26
Distributed	Nationwide (US)
Countries outside the US	BE, CA, DE, DK, FR, GB
Quantity	4,740 units
Reason classes	labeling
Lot numbers	`27231`, `27232`, `27233`, `27234`
Model numbers	`27231`, `27232`, `27233`, `27234`, `301040`

Product

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.

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."

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1793-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.