Events

Recall of DIMENSION EXL SYSTEM - TRIGLYCERIDES (TGL) ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    121387
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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)
  • Product Description
    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
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC