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
    28429
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-06
  • 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
    A malfunction with reagent dispensing on the abx pentra 400 (version 5.0.8 & lower) and pentra c400 (version 1.1.2 & lower) chemistry analyzers for the applications using 2 or more reagents in their assay reactions. could potentially lead to falsely low or falsely high results.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - INSTRUMENT W/ISE MODULE
  • Model / Serial
    Model Catalog: P4000000NUA1 (Lot serial: 361014384)
  • Product Description
    ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC