Events

Recall of VITROS 5600 INTEGRATED SYSTEM - SOFTWARE

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
    85472
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-02
  • 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
    Ocd has identified an anomaly with vitros 5600 integrated system software version 1.6 and below. internal testing determined that under very specific conditions a surfactant addition may inadvertently be added to a cuvetip or an empty cuvetip position for which it was not intended. please refer to the customer letter for details of the specific conditions in which this event may occur.

Device

VITROS 5600 INTEGRATED SYSTEM - SOFTWARE
  • Model / Serial
    Model Catalog: 680 2864 (Lot serial: Software Version 1.6 & below)
  • Product Description
    VITROS 5600 Integrated System - Software
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS