Events

Rappel de VITROS 5600 INTEGRATED SYSTEM - SOFTWARE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ORTHO-CLINICAL 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
    90870
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-28
  • 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
    Ocd has identified an anomaly with vitros 51 fs system version 2.6.1 software and below and vitros 5600 integrated system software version 2.0 and below. for the ease of workflow vitros analyzers allow multiple lots of the same reagent to be on board the system at the same time. the system automatically switches to the next lot when the "in use" lot is depleted or when the operator manually changes the lot that is in use. in this issue following a successful calibration of the new gens of vitros vanc [vancomycin] reagent (gen 21 and up) or vitros valp [valproic acid] reagent ( gen 16 and up) the system can unexpectedly switch and use the previous (old) lot on board the system to process post-calibration quality control samples. if the operator doesn't notice the lot switch condition code (pv2-097) posted on their screen the new calibration may not be verified by the proper quality control (qc) verification. based on that biased results could potentially occur from a calibration that is suboptimal.

Device

VITROS 5600 INTEGRATED SYSTEM - SOFTWARE
  • Modèle / numéro de série
    Model Catalog: 680 2864 (Lot serial: > 10 contact manufacturer.); Model Catalog: 6801886 (Lot serial: > 10 contact manufacturer.)
  • Description du dispositif
    VITROS 5600 Integrated System Software Version 2.0 & Below
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS