Events

Recall of VITROS DT60/DT6011 ANALYZER 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
    38405
  • Event Risk Class
    III
  • Event Initiated Date
    2011-10-25
  • 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 (ocd) has received several complaints regarding quality control fluid results that are below the measuring (reportable or dynamic) range for generation (gen) 72 of vitros chemistry products nbil dt slides when calibrated with vitros chemistry products dt calibrator kit lots 37 and 38.

Device

VITROS DT60/DT6011 ANALYZER CLASS 2
  • Model / Serial
    Model Catalog: (Lot serial: 37); Model Catalog: (Lot serial: 38)
  • Product Description
    VITROS Chemistry Products DT Calibrator Kit
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS