Events

Recall of COBAS IT MIDDLEWARE

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
    124087
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-17
  • 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
    In specific circumstances the evaluation of qc westgard rules can be performed incorrectly. rules comparing a quality control result with a previous result (or results) can be incorrectly assessed out of sequence. rules to assess a rising or falling trend in quality control results can also be wrongly evaluated. however the result released is correct.

Device

COBAS IT MIDDLEWARE
  • Model / Serial
    Model Catalog: 06498027001 (Lot serial: all versions); Model Catalog: 06498035001 (Lot serial: all versions)
  • Product Description
    COBAS IT MIDDLEWARE
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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