Events

Recall of ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS

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
    45862
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-10
  • 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
    During a complaint investigation at the manufacturer (horiba abx sas) a shift in the target value of the abx pentra n control was detected for potassium-e values related to the abx pentra 400 only. clinical laboratories will observe the potassium n control result will be reported in the lower range of the n control target range. the original target value annex shipped with the abx pentra n control lot#: 1300801 identified the potassium target value as 4.00 mmol/l with a target range of 3.70 -4.30 mmol/l (equivalent to 15.6 mg/dl with a target range of 14.4 -16.8 mg/dl). horiba abx sas (the manufacturer) has reassigned the target value and range a nd updated the annex for this lot number to reflect a target value of 3.76 mmol/land a target range of 3.46 - 4.06 mmol/l (equivalent to 14.7 mg/dl with a target range of 13.5 - 15-.9 mg/dl) for potassium. this issue is only applicable to potassium-e values reported on the abx pentra 400 chemistry analyzer with the ise module only. no other analyzers or other analyte values are affected.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS
  • Model / Serial
    Model Catalog: A11A01653 (Lot serial: 1300801)
  • Product Description
    ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC