Events

Recall of APTIMA URINE SPECIMEN COLLECTION KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC 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
    145703
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Labelling error - the inner pouches were incorrectly labelled as "aptima unisex swab collection kit for endocervical and male urethral swab specimens". the outer box of the kit is identified correctly as aptima urine collection kits.

Device

APTIMA URINE SPECIMEN COLLECTION KIT
  • Model / Serial
    Model Catalog: 301040-01 (Lot serial: 27232); Model Catalog: 301040-01 (Lot serial: 27234); Model Catalog: 301040-01 (Lot serial: 27233)
  • Product Description
    APTIMA Urine Specimen Collection Kit
  • Manufacturer
    GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC.

Manufacturer

GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC.
  • Manufacturer Address
    SAN DIEGO
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC