Events

Recall of COAGUCHEK XS SYSTEM - MONITOR

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
    25275
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-12
  • 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 coaguchek devices were designed with "error 6" serving as a fail-safe mechanism preventing inaccurate results caused by handing errors. however this "error 6" message might be displayed instead of the actual inr value. this problem might occur in patients with very long coagulation times i.E. high inrs such as those receiving treatment with vitamin k antagonists (i.E. warfarin) in combination with antibiotics and/or chemotherapeutics.

Device

COAGUCHEK XS SYSTEM - MONITOR
  • Model / Serial
    Model Catalog: 3666794 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 05448964001 (Lot serial: SN LESS THAN 6011000); Model Catalog: 04800842190 (Lot serial: SN LESS THAN 90000)
  • Product Description
    CoaguChek XS
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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