Events

Recall of 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
    Recall
  • Event ID
    33848
  • Event Risk Class
    Class 2
  • Event Number
    Z-0137-06
  • Event Date Posted
    2005-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42548
  • 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
    Fluorometer, For Clinical Use - Product Code KHO
  • Reason
    When using vitro eci immunodiagnostic system with vitros anti-hbc igm reagent packs and anti-hav igm reagent packs, results of the 1st of two required re-test replicates may be negtively biased.
  • Action
    Letters dated 9/29/2005 issued to all domestic customers of the VITROS ECi/ECiQ systems and to Ortho/J&J; foreign affiliates. Customers instructed to immediately discontinue using reflex processing to the VITROS Anti-HBc IgM and VITROS Anti-HAV reagent packs.

Device

Vitros
  • Model / Serial
    All Vitros ECi units currently on the market (software version 3.1 or lower).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
  • Product Description
    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA