Events

Rappel de VITROS CHEMISTRY PRODUCTS SYSTEM - ALT SLIDES (ALKALINE AMINOTRANSFERASE)

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
    55603
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-02-13
  • 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 received complaints of lower than expected results (<6 u/l) for samples that were known to be outside of the measuring range (>1000 u/l) when using calibration diskette/assay data diskette data release version (drv) 5653 through 5666 and vitros chemistry products alt slides (gen 26). internal investigation determined that the diskettes did not contain the appropriate supplementary calibration data for vitros alt slides (gen 26) used to flag samples greater than 1000 u/l that may have depleted the substrate. sample results that were reported between 6-1000 u/l are not affected by this issue. to correct the issue all customers that received vitros alt slides (gen 26) will be shipped drv 5667 which contains revised supplementary calibration data that will appropriately flag a sample that causes substrate depletion. following download and successful recalibration it is acceptable to resume using vitros alt slides (gen 26).

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - ALT SLIDES (ALKALINE AMINOTRANSFERASE)
  • Modèle / numéro de série
    Model Catalog: 1655281 (Lot serial: 622-0421-0410)
  • Description du dispositif
    VITROS Chemistry Products ALT Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS