Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - CALIBRATOR 1

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
    144126
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-10
  • 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
    Ortho clinical diagnostics determined that calibrator values (data/calibration mathematics) for vitros fs calibrator 1 lot 91461 are not available for selection on the assay data diskettes drvs 5904 through 5910. vitros fs calibrator 1 is used on vitros systems to calibrate the following assays: vitros amph aso barb benz cocm d%a1c dldl hscrp pcp rf and thc reagents.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - CALIBRATOR 1
  • Model / Serial
    Model Catalog: 680 1873 (Lot serial: 91461)
  • Product Description
    VITROS 51 FS Chemistry Products Calibrator 1
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS