Events

Recall of TITAN GEL ALKALINE PHOSPHATASE (HR) 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
    53851
  • Event Risk Class
    III
  • Event Initiated Date
    2016-11-15
  • 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
    Upon investigation into complaints from customers helena laboratories has confirmed that control values for this lot of gel alkaline phosphatase isoenzyme control have fallen outside the acceptable range. when control values fall outside of the acceptable range the run is considered invalid. results from an invalid run cannot be reported and the run needs to be repeated.

Device

TITAN GEL ALKALINE PHOSPHATASE (HR) KIT
  • Model / Serial
    Model Catalog: 5104 (Lot serial: 1-16-5104)
  • Product Description
    GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL
  • Manufacturer
    INTER MEDICO

Manufacturer

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