Gen-Probe Recalls APTIMA Urine Collection Kits Due to Labeling Error
Gen-Probe Inc is recalling APTIMA Urine Collection Kits because inner pouches are mislabeled as swab collection kits.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is limited to packaging labeling errors.
Plain-English summary
Gen-Probe Inc is recalling 4,740 units of APTIMA Urine Collection Kits, Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. The recall is due to incorrect labeling on the inner pouches of the kits.
The outer boxes are correctly identified as "APTIMA Urine Collection Kits," but the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens." The affected products were distributed worldwide, including the United States, Canada, Denmark, France, Germany, Belgium, and the United Kingdom.
The U.S. Food and Drug Administration has classified this as a Class III recall. Consumers and healthcare facilities should stop using the affected lots and contact Gen-Probe Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Gen-Probe Inc
- Hazard
- Affected units
- 4,740
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog #301040. Lot Numbers: 27231
- 27232
- 27233
- 27234. Expriation Date: 31JAN2015.
Distribution
Distributed nationwide across the United States.
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