Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY 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
    51422
  • Event Risk Class
    III
  • Event Initiated Date
    2010-04-20
  • 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 product correction notice has been issued because of a problem with microslide reagent management on the vitros 5600 integrated system (software version 1.3.2 and below) and on the vitros 51 fs chemistry system (software version 2.5 and below). under certain condition the affected systems may process results from a cartridge other than the intended cartridge.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - SOFTWARE
  • Model / Serial
    Model Catalog: 6801886 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 680 2863 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 6801885 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 680 2864 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    VITROS 51 FS CHEMISTRY SYSTEM SOFTWARE
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS