Events

Recall of VITROS CHEMISTRY PRODUCTS WHITE CORRECTION FACTOR SLIDES

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
    51052
  • Event Risk Class
    II
  • Event Initiated Date
    2014-01-13
  • 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
    Ocd has initiated a recall as it has determined that one lot of vitros white correction factor slides was released with an incorrect assay value for the 460nm wavelength filter. the labeling for the vitros white reference slides lot 9052-0045-6358 incorrectly indicates an assay value of 0.3785 for the 460nm filter versus the actual assay value of 0.8658. all other assay values listed are correct. the 460nm wavelength is only used to determine the predicted concentration when processing vitros tbil slides or vitros bubc slides.

Device

VITROS CHEMISTRY PRODUCTS WHITE CORRECTION FACTOR SLIDES
  • Model / Serial
    Model Catalog: J02315 (Lot serial: 9052-0045-6358)
  • Product Description
    VITROS WHITE CORRECTION FACTOR SLIDES
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS