Events

Recall of PROTIME MICROCOAGULATION SYSTEM (FOR PATIENT SELF TESTING) - INSTRUMENT

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

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
    24962
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-25
  • 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
    A limited number of protime instruments were manufactured with a component that may contribute to a small decrease in performance and may cause inconvenience. affected instruments have a potential to yield either an error code (no test) or a slightly lower than actual pt/inr result when the inr is greater than 3.5.

Device

PROTIME MICROCOAGULATION SYSTEM (FOR PATIENT SELF TESTING) - INSTRUMENT
  • Model / Serial
    Model Catalog: PROTIMEPRO (Lot serial: Serial Number: V-71458)
  • Product Description
    ProTime Microcoagulation System
  • Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.

Manufacturer

INTERNATIONAL TECHNIDYNE CORP.
  • Manufacturer Address
    EDISON
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    HC