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
    56769
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-16
  • 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
    There is a potential sample mismatch that could occur between samples processed on the same rack on the cobas 6500 u601 urine analyzer and/or cobas u701 microscopy analyzer. the issue can occur if the sensors are misadjusted (either after transportation of the instrument or service has been performed on the sensor itself). there is no indication that the sensors can become misadjusted during operation. the analyzer may not transport the rack correctly so that tubes might be detected twice. as a consequence the same tube barcode label is read twice and the last tube barcode label is interpreted as the rack identification (id). hence a sample mismatch is possible between samples processed on the same rack because the tubes are pipetted in the order given by the rack position and the test result is assigned to the wrong sample id.

Device

COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
  • Model / Serial
    Model Catalog: 06390498001 (Lot serial: ALL); Model Catalog: 06390501001 (Lot serial: All)
  • Product Description
    COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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