Events

Recall of ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - MAGNESIUM RTU 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
    121359
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-26
  • 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
    Potential that customers running the magnesium rtu assay on the abx pentra 400 chemistry analyzers that on-board stability has been updated. user will be unable to calibrate the magnesium rtu assay after 1 day of on-board (on instrument use) the control will be out of range at values lower than target values. the result reported using this failed calibration will be flagged "cal_error" displayed on the results with a "c".

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - MAGNESIUM RTU ASSAY
  • Model / Serial
    Model Catalog: A11A01646 (Lot serial: all)
  • Product Description
    ABX PENTRA Magnesium RTU
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC