Events

Recall of THINPREP 2000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by 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
    31592
  • Event Risk Class
    III
  • Event Initiated Date
    2015-06-24
  • 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
    Hologic has recently been notified by health canada regarding classification of the thinprep 2000 and thin prep 5000 processors. these products entered the canadian market as class i devices and it has been determined that these should be classified as class iii. this reclassification is the result of an administrative error and is completely unrelated to the safety and effectiveness of the thin prep processors. there are no issues or concerns with the safe and effective use of the thin prep 2000 or the thin prep 5000 processors and the integrity of all past current and future tests are not in question.

Device

THINPREP 2000
  • Model / Serial
    Model Catalog: 70031-001 (Lot serial: All lots); Model Catalog: 70031-002 (Lot serial: All lots); Model Catalog: 71362-001 (Lot serial: All lots); Model Catalog: 71362-002 (Lot serial: All lots)
  • Product Description
    ThinPrep 2000 Processor
  • Manufacturer
    HOLOGIC INC.

Manufacturer

HOLOGIC INC.
  • Manufacturer Address
    MARLBOROUGH
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC