Recall of Device Recall VITROS

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Ortho-clinical diagnostics is recalling vitros chemistry systems due to possible internal hard drive failure.
  • Action
    Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS¿ System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.


  • Model / Serial
    Serial number range: 46000108 - 46000157
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution
  • Product Description
    VITROS® 4600 Chemistry System, Product Code: 6802445 || Product Usage: || For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immuno rate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
  • Manufacturer


  • Manufacturer Address
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Manufacturer Parent Company (2017)
  • Source