Events

Recall of COBAS U 411 URINALYSIS ANALYZER

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
    25276
  • Event Risk Class
    I
  • Event Initiated Date
    2010-11-30
  • 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
    Under certain circumstances the cobas u 411 is transmitting to the lis the lowest possible value of the assigned range table in combination with the t-flag. generally the lowest possible value of the range table is "neg". as a result false negative results could be present in the lis patient file which could have an impact on the medical decision.

Device

COBAS U 411 URINALYSIS ANALYZER
  • Model / Serial
    Model Catalog: 04906969001 (Lot serial: >10 contact manufacturer)
  • Product Description
    Cobas U 411 Urinalysis Analyzer
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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