Events

Safety Alert for ProTime Microcoagulation System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by International Technidyne Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-06-28
  • Event Date Posted
    2012-06-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120627c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: protime microcoagulation system the health canada posted a medical device recall notice concerning protime microcoagulation system, manufactured by international technidyne corporation. the affected model is protimepro and the affected lot is v-71458. according to the notice, a limited number of protime instruments were manufactured with a component that may contribute to a small decrease in performance and may cause inconvenience. the 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. for details, please refer to health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/ recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 28 jun 2012.

Device

ProTime Microcoagulation System

Manufacturer

International Technidyne Corporation