Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - REFURBISHED ANAL. CLASS 2

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
    74006
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-05
  • 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 issued a recall pertaining to a potential malfunction in a wire connector used in the vitros 4600 vitros 5600 and vitros 51 fs systems that were shipped during a specific date range. to date six customers reported the smell of melting plastic or observed smoke originating from their vitros 4600 and 5600 systems. although reports are confined to the vitros 4600 and 5600 systems the same wire connector is also used on vitros 51 fs systems. as a precaution ocd is contacting customers to notify them of this potential malfunction for vitros systems that were shipped during a specific date range.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - REFURBISHED ANAL. CLASS 2
  • Model / Serial
    Model Catalog: 6801890 (Lot serial: 34001610); Model Catalog: 6801890 (Lot serial: 34001589); Model Catalog: 680 2445 (Lot serial: 46000159); Model Catalog: 680 2445 (Lot serial: 46000140); Model Catalog: 680 2445 (Lot serial: 46000160); Model Catalog: 680 2445 (Lot serial: 46000142); Model Catalog: 680 2445 (Lot serial: 46000115); Model Catalog: 6802413 (Lot serial: 56001220); Model Catalog: 6802413 (Lot serial: 56001229); Model Catalog: 6802413 (Lot serial: 56001205); Model Catalog: 6802413 (Lot serial: 56001234); Model Catalog: 6802413 (Lot serial: 56001231); Model Catalog: 6802413 (Lot serial: 56001222); Model Catalog: 680 2413 (Lot serial: 56001220); Model Catalog: 680 2413 (Lot serial: 56001229); Model Catalog: 680 2413 (Lot serial: 56001205); Model Catalog: 680 2413 (Lot serial: 56001234); Model Catalog: 680 2413 (Lot serial: 56001231); Model Catalog: 680 2413 (Lot serial: 56001222)
  • Product Description
    VITROS 51 Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS