Events

Recall of PLATELET ANTIBODY SCREENING KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTER MEDICO.

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
    34685
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-15
  • 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
    The manufacturer gen-probe gti diagnostics has recently notified us that they have observed anomalous increases in the optical density (od) of the negative control used with certain lifecodes assays. as a precautionary measure the expiration date of the negative control used with certain assays has been shortened. kits not listed in this letter are either not affected by the change in expiry or the labeling represents the appropriate expiration date.

Device

PLATELET ANTIBODY SCREENING KIT
  • Model / Serial
    Model Catalog: PAKPLUS (Lot serial: MORE THEN 10 CONTACT MFR); Model Catalog: PAK12 (Lot serial: MORE THEN 10 CONTACT MFR); Model Catalog: PAK12-G (Lot serial: MORE THEN 10 CONTACT MFR)
  • Product Description
    PLATELET ANTIBODY SCREENING KIT
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Inter Medico
  • Source
    HC