Events

Recall of IH-1000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO-RAD LABORATORIES (CANADA) LTD..

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
    26370
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-22
  • 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
    When a reagent vial with an unreadable barcode is loaded on a reagents rack on ih-1000 (software version 04.07.02) and a test is performed despite the fact the first reagent is correctly pippetted the instrument will pipette in the vial with unreadable barcode for all the remaining wells.

Device

IH-1000

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.