Events

Rappel de VITROS CHEMISTRY PRODUCTS SYSTEM - CREA SLIDES (CREATININE)

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
    104022
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-06-14
  • 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 received an increase in customer complaints related to slide dispense issues with some vitros chemistry products slides. this increase is due to the anti-backup platen (abp) failing to advance inside the vitros chemistry products slide cartridge body causing an increase in condition codes on the vitros system. the abp is a plastic platform that supports the slide stack inside the cartridge and is pushed along with the slides to the top of the cartridge during the slide dispense cycle. if the abp is jammed within the cartridge body a slide will not be properly positioned to dispense and the system will generate a condition code. this can lead to system downtime as the user must remove the cartridge and re-seat the abp in the slide cartridge or replace it with a new cartridge.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - CREA SLIDES (CREATININE)
  • Modèle / numéro de série
    Model Catalog: 680 2584 (Lot serial: > 10 contact manufacturer); Model Catalog: 1988211 (Lot serial: > 10 contact manufacturer); Model Catalog: 8343386 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801895 (Lot serial: > 10 contact manufacturer); Model Catalog: 1053180 (Lot serial: > 10 contact manufacturer); Model Catalog: 8102204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8001133 (Lot serial: > 10 contact manufacturer); Model Catalog: 8058232 (Lot serial: > 10 contact manufacturer); Model Catalog: 8297749 (Lot serial: > 10 contact manufacturer); Model Catalog: 8159931 (Lot serial: > 10 contact manufacturer); Model Catalog: 1668409 (Lot serial: > 10 contact manufacturer); Model Catalog: 1707801 (Lot serial: > 10 contact manufacturer); Model Catalog: 1921204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8255093 (Lot serial: > 10 contact manufacturer); Model Catalog: 1612365 (Lot serial: > 10 contact manufacturer); Model Catalog: 8383051 (Lot serial: > 10 contact manufacturer)
  • Description du dispositif
    VITROS CREA Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS