June 25, 2014Medical DevicesFDA
Gen-Probe Inc recalls APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA
Hazard: 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."