FDA Devices recall · Reported June 25, 2014
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.
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 Collec…
Gen-Probe Inc recalled APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234.… - a low-severity action.
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234.… was recalled by Gen-Probe Inc in June 25, 2014. Reason: Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The …. Check the official notice for the remedy. Verify recall #Z-1793-2014 with the FDA Devices before acting.
The recall
Gen-Probe Inc issued this low-severity FDA Devices recall-Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The ….
- Low
- severity level
- 5K units
- affected scope
- Class III
- classification
- June 25, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1793-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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."
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1793-2014 |
| Date reported | June 25, 2014 |
| Date initiated | April 17, 2014 |
| Recalling firm | Gen-Probe Inc |
| Firm location | San Diego, CA |
| Affected scope | 4,740 units |
| Distribution | 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). |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1793-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026