Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II

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
    52233
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-10
  • 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 announced a recall to inform customers of a change to the frequency of replacement for the cm/rt wear pads on vitros 5600 4600 and 51 fs systems. cm/rt wear pads are a component in the cm/rt incubator. the cm/rt rotor revolves on three wear pads within the incubator. by design there is a small gap between the rotor and the hot plate to allow for the transfer of heat. if the wear pads become too thin it may cause the rotor to rub on the hot plate resulting in black dust within the incubator. the impact of black dust may contribute to unplanned system down time. we have no data that suggests that black dust has any adverse effect on results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Model / Serial
    Model Catalog: 6801375 (Lot serial: > 10 contact manufacturer); Model Catalog: 6802413 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801890 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2445 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS 51 FS Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS