Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - INSTRUMENT

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
    46653
  • Event Risk Class
    II
  • Event Initiated Date
    2008-03-13
  • 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 failed capacitor on the reflectometer dsp circuit board within the vitros 51 fs system failed and fell off into the slide waste container below resulting in a small fire.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 6801375 (Lot serial: S/N LESS THAN 34001351)
  • Product Description
    VITROS 51 FS CHEMISTRY SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS