Events

Rappel de VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

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
    91139
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-04-14
  • 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 issued a recall due to the potential for biased results when a multiple window (mw) code is associated with results generated by the vitros 5600 integrated system vitros 4600 chemistry system and vitros 51 chemistry system. mw codes may be associated with results from any of the following vitros chemistry products using multiple point (multipoint) rate measurements: alt slides alkp slides ast slides che slides ck slides ggt slides ldh slides. multipoint rate assays measure enzyme activity via multiple readings which are used to generate a kinetic curve and calculate results. the mw algorithm assesses the validity of the kinetic curve. an mw code is generated if a single point exceeds predetermined limits provided that all surrounding values are within acceptable limits.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Modèle / numéro de série
    Model Catalog: 680 2413 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 6801375 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 680 2445 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 6801890 (Lot serial: > 10 numbers contact mfg.)
  • Description du dispositif
    VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS