Recall Z-1793-2014— Gen-Probe Inc

Name: FDA recall Z-1793-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-17

Class III · Terminated

Class III FDA medical device recall by Gen-Probe Inc, initiated 2014-04-17, terminated 2014-08-26. It names one FDA 510(k) clearance: K003395. 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.".

Recalling firm: Gen-Probe Inc
Classification: Class III
Status: Terminated
Initiated: 2014-04-17
Terminated: 2014-08-26
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K003395 — GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.·cleared 2001-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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."

Data sourced from openFDA. This site is unofficial and independent of the FDA.