Events

Recall of ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CALCIUM 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
    34059
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-16
  • 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 qc testing the other equipment manufacturer (oem) discovered precipitates in some of the r2 reagent casettes of the abx pentra calcium cp (a11a01633) from the lot #: 014664503. the initial functional tests conducted by the oem indicate there is currently no effect on patient results. however in a previous lot the oem did identify aberrant results related to the presence of these precipitates. therefore with time there may be an increase in the quantity of precipitates and by extension a risk of incorrect patient results being reported.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CALCIUM CP ASSAY
  • Model / Serial
    Model Catalog: A11A01633 (Lot serial: 014664503)
  • Product Description
    ABX PENTRA CALCIUM CP REAGENT
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC