Events

Recall of Urine Specimen Collection Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gen-Probe Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68229
  • Event Risk Class
    Class 3
  • Event Number
    Z-1793-2014
  • Event Initiated Date
    2014-04-17
  • Event Date Posted
    2014-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127184
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Urine collection kit (excludes hiv testing) - Product Code OIE
  • 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: molecularsupport@hologic.com

Device

Urine Specimen Collection Kit
  • Model / Serial
    Catalog #301040.  Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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).
  • 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.
  • Manufacturer
    Gen-Probe Inc

Manufacturer

Gen-Probe Inc
  • Manufacturer Address
    Gen-Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    USFDA