Events

Rappel de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II

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
    22543
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-04-07
  • 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 inc. (ocd) has confirmed instances where the vitros system allowed urine samples for assays that required acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed. this has been attributed to a software anomaly. depending upon the assay urine samples either need to be acidified alkalized or require no pretreatment. the anomaly occurs when manually programming urine samples or using a downloaded sample program from a laboratory information system (lis) and the sample program contains assays requiring sample pretreatment and assays requiring no sample pretreatment. if this anomaly occurs it is possible for vitros 51 4600 or 5600 systems to process urine samples without the proper pretreatment potentially leading to biased patient results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Modèle / numéro de série
    Model Catalog: 6801890 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6802413 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6801375 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6802445 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    VITROS 51 FS CHEMISTRY (DEVICE LICENCE #66236)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS