Recall Z-1793-2014 ยท OIE Urine Collection Kit (Excludes Hiv Testing)
Gen-Probe Inc
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.
| Date | Jun 14, 2014 (initiated Apr 17, 2014) |
| Status | Terminated |
| 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." |
| Root cause | Labeling mix-ups |
| Action | Hologic sent a Recall Notice letter dated April 14, 2014 via overnight mail (FedEx) to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter requests customers to: 1. segregate the entire contents of the affected kit lots 2. reconcile and destroy all partial and/or full kits remaining in inventory and to document; the amount destroyed on the Customer Response Form provided with the Recall Notice; 3. if the urine collection kits were further distributed to other collection sites, then to notify them of this issue; and 4. com |
| Quantity | 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). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003395 | GEN-PROBE APTIMA COMBO 2 ASSAY Gen-Probe, Inc., May 21, 2001 |