FDA Device recall Z-1793-2014
APTIMA Urine Collection Kit
- FDA Device
- Class III
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class III recall of APTIMA Urine Collection Kit by Gen Probe, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1793-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-04-17 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Gen Probe |
| Distribution | US |
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
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."
Identifiers
| code_info | Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1793-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.