Events

Rappel de DIMENSION EXL SYSTEM - TRIGLYCERIDES (TGL) 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
    121387
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-03-24
  • 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 become aware of n-acetylcysteine (nac) and metamizole (dipyrone) interference with trinder and trinder-like reaction assays. the trinder reaction is a reaction where hydrogen peroxide is formed and subsequently reacts with a phenol derivative and aminoantipyrine in the presence of peroxidase to form a coloured quinone product. siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving n-acetylcysteine (nac) or metamizole. nac is the accepted antidote for acetaminophen toxicity and is justified in patients at significant risk for hepatotoxicity. metamizole is an anti-inflammatory anti-pyretic drug banned in most countries because of the potential for nephrotoxicity. the instructions for use (ifu) for the assays will be updated to indicate that: venipuncture should occur prior to n-acetylcysteine (nac) or metamizole administration due to the potential for falsely depressed results.

Device

DIMENSION EXL SYSTEM - TRIGLYCERIDES (TGL) ASSAY
  • Modèle / numéro de série
    Model Catalog: DF69A (Lot serial: all lots); Model Catalog: DF77 (Lot serial: all lots); Model Catalog: 10444906 (Lot serial: all lots); Model Catalog: DF270B (Lot serial: all lots); Model Catalog: 10471520 (Lot serial: all lots); Model Catalog: 10444967 (Lot serial: all lots); Model Catalog: DF48B (Lot serial: all lots); Model Catalog: 10464332 (Lot serial: all lots); Model Catalog: K3048A (Lot serial: all lots); Model Catalog: K1270A (Lot serial: all lots); Model Catalog: 10464340 (Lot serial: all lots); Model Catalog: K2069 (Lot serial: all lots); Model Catalog: K1077 (Lot serial: all lots)
  • Description du dispositif
    DIMENSION EXL SYSTEM - TRIGLYCERIDES (TGL) ASSAY;DIMENSION XPAND SYSTEM - URIC ACID (URCA) ASSAY;DIMENSION XPAND SYSTEM - TRIGLYCERIDES (TGL) ASSAY;DIMENSION CLINICAL CHEMISTRY SYS - ENZYMATIC CREATININE ECRE FLEX REAG CART;DIMENSION CLINICAL CHEMISTRY SY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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