Events

Recall of ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - TRIGLYCERIDES CP ASSAY

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

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
    47434
  • Event Risk Class
    III
  • Event Initiated Date
    2016-01-22
  • 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
    Nacetylcysteine present in the blood of patients treated for paracetamol overdose can interfere with the trinder action that uses hydrogen peroxide catalytic on aminoantipyrine and phenol and can produce falsely low results with the reagents using the trinder reaction method.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - TRIGLYCERIDES CP ASSAY
  • Model / Serial
    Model Catalog: A11A01640 (Lot serial: na); Model Catalog: A11A01721 (Lot serial: na); Model Catalog: A11A01670 (Lot serial: na); Model Catalog: A11A01634 (Lot serial: na)
  • Product Description
    ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM;LACTIC ACID 260ML;uric acid cp 220T;CHOLESTEROL CP 380T
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC