Events

Rappel de ENGEN AUTOMATED SAMPLE HANDLING SYSTEM

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
    101180
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-09-08
  • 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 pertaining to engen systems configured with a thermo scientific centrifuge module and tcautomation (tca) software versions 3.6.1 and below. ortho became aware of one confirmed instance of test results that were mis-associated with the wrong sample id (sid) and were reported prior to the engen system detecting the sid mismatch. assay results are potentially associated with the wrong patient and reported out of the laboratory. this could lead to inappropriate intervention with the potential for serious injury to the patient. ortho received no reports of patient injury due to this issue.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Modèle / numéro de série
    Model Catalog: ENGEN (Lot serial: JCT20Q3J); Model Catalog: ENGEN (Lot serial: J16XQH4J); Model Catalog: ENGEN (Lot serial: J41BCY4J); Model Catalog: ENGEN (Lot serial: J953244)
  • Description du dispositif
    enGen Laboratory Automation System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS