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
    114189
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-11
  • 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
    Ortho clinical diagnostics (ortho) has initiated this recall due to a vitros system software timing anomaly that could cause two different sample metering scenarios that may lead to erroneous results. scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample. scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) causing sample b to be contaminated and diluted by sample a.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Modèle / numéro de série
    Model Catalog: 680 2413 (Lot serial: 36000264); Model Catalog: 680 2413 (Lot serial: 36000773); Model Catalog: 680 2413 (Lot serial: 36000627); Model Catalog: 680 2413 (Lot serial: >10 serial numbers affected); Model Catalog: 680 2783 (Lot serial: >10 serial numbers affected); Model Catalog: 680 2783 (Lot serial: 36000627); Model Catalog: 680 2783 (Lot serial: 36000264); Model Catalog: 680 2783 (Lot serial: 36000773)
  • Description du dispositif
    VITROS 5600 Integrated System;VITROS 3600 Immunodiagnostics System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS