Events

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
    Recall
  • Event ID
    25319
  • Event Risk Class
    Class 3
  • Event Number
    Z-0557-03
  • Event Initiated Date
    2002-12-18
  • Event Date Posted
    2003-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25592
  • 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 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 data.
  • Extra notes in the data
  • Reason
    Cartons labeled 'tdm performance verifier i' may contain tdm performance verified ii.
  • Action
    Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.

Device

Device Recall Vitros
  • Model / Serial
    T3606, Exp 31 Mar 2004
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).
  • Product Description
    CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14650-0881
  • Source
    USFDA