Events

Recall of IDS-ISYS - WASH SYSTEM

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
    15619
  • Event Risk Class
    III
  • Event Initiated Date
    2014-01-29
  • 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 ids continual quality monitoring program has identified that a very small number of wash solution containers have been manufactured without adding the concentrated solution. the potential hazard associated with the use of the device is an increase in the imprecision and a bias relative to the true concentration of samples measured using the ids-isys assays on board the ids-isys analyser.

Device

IDS-ISYS - WASH SYSTEM
  • Model / Serial
    Model Catalog: IS-CW100 (Lot serial: 75496); Model Catalog: IS-CW100 (Lot serial: 76208)
  • Product Description
    IDS-ISYS-WASH SYSTEM
  • Manufacturer
    INTER MEDICO

Manufacturer

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