BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1793-2014 · Initiated April 17, 2014

    Recall

    Recall Number
    Z-1793-2014
    Event Number
    68229
    Firm
    Gen-Probe Inc
    FEI Number
    2024800
    Product Code
    OIE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 17, 2014
    Posted
    June 14, 2014
    Terminated
    August 26, 2014
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    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

    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."

    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. complete and return the Customer Response Form to Technical Support (contact information is provided in the notification letter). For additional information, questions, or concerns, contact Hologic Molecular (Technical) Support. Toll Free: 888-484-4747 Direct: 858-410-8511 Fax: 858-410-8250 Email: [email protected]

    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).

    Quantity

    4,740 units