Events

Rappel de COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ROCHE DIAGNOSTICS.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56769
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-01-16
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Model Catalog: 06390498001 (Lot serial: ALL); Model Catalog: 06390501001 (Lot serial: All)
  • Description du dispositif
    COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Adresse du fabricant
    LAVAL
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    HC