Events

Recall of COBAS B221 SYSTEM - REFERENCE ELECTRODE

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
    67582
  • Event Risk Class
    I
  • Event Initiated Date
    2014-02-04
  • 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 cobas b221 reference electrode has a lifetime of 52 weeks but is not documented in the analyzer manual. customers had not been sufficiently informed regarding this limitation. they may find themselves using aged electrodes leading to leakage. ultimately this may cause a ph and a na+ offset which may result by incorrect diagnosis and treament.

Device

COBAS B221 SYSTEM - REFERENCE ELECTRODE

Manufacturer

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