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
    121013
  • 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 (ocd) internal testing has confirmed instances where vitros 51 fs 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen regardless of the pretreatment requirements for each selected assay potentially leading to biased patient results. urine samples for use with vitros ca mg and phos slides require acidification (pretreatment). the engen system software currently does not route these samples to the manual high priority exit location for pretreatment as intended. in addition the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pretreatment. depending upon the assay urine samples need to be acidified alkalized extracted or not treated prior to being processed on vitros systems.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Modèle / numéro de série
    Model Catalog: ENGEN (Lot serial: J953234); Model Catalog: ENGEN (Lot serial: J41BCY4J); Model Catalog: ENGEN (Lot serial: J16XQH4J); Model Catalog: ENGEN (Lot serial: J1HX7S4J); Model Catalog: ENGEN (Lot serial: J953244); Model Catalog: ENGEN (Lot serial: JCT20Q3J)
  • Description du dispositif
    ENGEN LABORATORY AUTOMATION SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS