Events

Rappel de DIMENSION XPAND SYSTEM - AMMONIA (AMM) ASSAY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    101639
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-03-07
  • 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
    In september 2014 siemens healthcare diagnostics issued customer notification 14-62 that addressed a high rate of "abnormal assay" test report messages for its dimension ammonia (amm) assay. with this letter siemens is reducing the amm open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. dimension amm ifu revision e will reflect this change. the new version of dimension software 10.2 will do the following: -automatically move to a new well every day. this decrease in the open well maximum duration reduces the amount of time the amm reagent is exposed to any potential contaminates reduces the need for customers to manually move to a new reagent well and aids in the prevention of erroneous flagging. -contain the below mean factor limit of 0.90. siemens is working to make dimension software10.2 available to all customers as quickly as possible.

Device

DIMENSION XPAND SYSTEM - AMMONIA (AMM) ASSAY
  • Modèle / numéro de série
    Model Catalog: 10711991 (Lot serial: ALL); Model Catalog: DF119 (Lot serial: ALL)
  • Description du dispositif
    DIMENSION XPAND SYSTEM-AMMONIA (AMM) ASSAY;DIMENSION EXL SYSTEM-AMMONIA (AMM) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC