Events

Rappel de RAPIDPOINT 500 SYSTEM - LACTATE MEASUREMENT CARTRIDGES

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
    57900
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-05-30
  • 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
    Siemens healthcare diagnostics has received several reports from customers of one or more electrolyte parameters (e.G. na+ ca++ k+ cl-) reporting a "-----?" error code when aqc qc or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited the tissue is usually seen during level 1 qc/aqc level 1 cvm and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples. this issue impacts only rapidpoint 500 measurement cartridges p/ns 10491447 10491448 10491449 and 10844813. siemens has observed this issue with rapidpoint 500 measurement cartridges with serial numbers up to 2412705915 however not all these cartridges will exhibit this behavior. the issue does not impact rapidpoint 400 or rapidpoint 405 measurement cartridges.

Device

RAPIDPOINT 500 SYSTEM - LACTATE MEASUREMENT CARTRIDGES
  • Modèle / numéro de série
    Model Catalog: 10491447 (Lot serial: 2334500011 THROUGH 2412705915); Model Catalog: 10491448 (Lot serial: 2334500011 THROUGH 2412705915); Model Catalog: 10491449 (Lot serial: 2334500011 THROUGH 2412705915); Model Catalog: 10844813 (Lot serial: 2334500011 THROUGH 2412705915)
  • Description du dispositif
    RAPIDPOINT 500 SYSTEM - LACTATE MEASUREMENT CARTRIDGES
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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