Events

Recall of BM HITACHI 902/911/912/917 ANALYZER - CLASS 3

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

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
    42407
  • Event Risk Class
    II
  • Event Initiated Date
    2000-04-07
  • 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
    Mismatch potential of sample identification and results while the analyser is in "reagent interrupt or sample stop" on all versions of software on hitachi 917 disk analyser.

Device

BM HITACHI 902/911/912/917 ANALYZER - CLASS 3
  • Model / Serial
    Model Catalog: (Lot serial: model 7140029)
  • Product Description
    hitachi 917 disk analyser
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC