Events

Recall of ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - INSTRUMENT W/ISE MODULE

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
    84479
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-03
  • 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
    As per the manufacturer during a complaint investigation it was determined that the abx pentra 400 does not provide a low or high out of linearity range flag for ise results (i.E. sodium chloride and potassium). the only flag that is present in these situations is the ref-range_low or _high analysis flags and an "l" or "h" flag on the patient report. there was no alarm informing the user that the value was outside of the instrument's linearity limits. the lack of an out of linearity range flag without any indication that the results may actually be invalid due to the linearity limits being exceeded. this is a software design oversight for the abx pentra 400 i.S.E. module instruments.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - INSTRUMENT W/ISE MODULE
  • Model / Serial
    Model Catalog: P4000000NUA1 (Lot serial: all serial)
  • Product Description
    ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC