Events

Recall of ORTHO PROVUE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    151358
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-02
  • 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
    Ortho clinical diagnostics has identified a software anomaly when using ortho provue software version 3.1. internal testing has revealed that the analyzer did not dispense plasma following a cancelled microtube due to an error that occurred during pipetting. when this occurred the analyzer did not generate a card volume error as expected which allowed potentially erroneous test results to be reported.

Device

ORTHO PROVUE
  • Model / Serial
    Model Catalog: MTS213784 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    ORTHO PROVUE ANALYZER SOFTWARE V. 3.1
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS