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
    23772
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-04
  • 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 manufacturer has identified during internal investigation following customer injury complaints that a new mandatory cleaning procedure for sample rack trays was required to mitigate the risk of > potential user injury.

Device

COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
  • Model / Serial
    Model Catalog: 06390498001 (Lot serial: More than 100 contact manuf.); Model Catalog: 07649142001 (Lot serial: More than 100 contact manuf.); Model Catalog: 04745922001 (Lot serial: More than 100 contact manuf.); Model Catalog: 28122474001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05964067001 (Lot serial: More than 100 contact manuf.); Model Catalog: 03051323001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05990378001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05412722001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05524245001 (Lot serial: More than 100 contact manuf.); Model Catalog: 06473245001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05641489001 (Lot serial: More than 100 contact manuf.); Model Catalog: 04775201001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05082579001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05083435001 (Lot serial: More than 100 contact manuf.); Model Catalog: 03530744001 (L
  • Product Description
    COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE;COBAS C 513 ANALYZER;COBAS 6000 - E601;COBAS INTEGRA SYSTEM - COBAS INTEGRA 800 ANALYZER;COBAS 8000 C502 STAND ALONE CONFIGURATION;URISYS 2400 ANALYSER;COBAS 8000 E602 IMMUNOASSAY ANALYZER;COBAS 8800;COBAS
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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