Events

Recall of COBAS 6500 U601 URINALYSIS SYSTEM - URINE 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
    23720
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-22
  • 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
    During internal investigation our manufacturer confirmed a possible software issue where the strips cassettes (cobas upack) on cobas u601 urinalysis system is denied by the user software although the expiry date has not been reached. this is true for every month reaching the cassette expiry date.

Device

COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
  • Model / Serial
    Model Catalog: 06390498001 (Lot serial: Software v. less or eq 2.2.1.); Model Catalog: 06390501001 (Lot serial: Software v. less or eq 2.2.1.)
  • Product Description
    COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE;COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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