Z-1793-2014 Class III Terminated
FDA device recall Z-1793-2014 was initiated by Gen-Probe Inc on April 17, 2014 and is designated Class III. 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 recall status is terminated (terminated August 26, 2014). Affected quantity: 4,740 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2014
- Initiation Date
- April 17, 2014
- Termination Date
- August 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,740 units
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."
Distribution Pattern
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).
Code Information
Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.