Events

Recall of COBAS INTEGRA GLUCOSE HK GEN.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
    29768
  • Event Risk Class
    III
  • Event Initiated Date
    2010-09-07
  • 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
    A change must be made to the glucose urine application of the cobas c501 unit of cobas 6000 analyzer due to precision problems and outliers when using aqueous urine control materials at a concentration level of 1.4 mmol/l.

Device

COBAS INTEGRA GLUCOSE HK GEN.3
  • Model / Serial
    Model Catalog: (Lot serial: All lots)
  • Product Description
    Cobas Integra Glucose HK Gen. 3
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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