Events

Recall of Clinical Chemistry Urea Nitrogen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories Diagnostic Div.

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
    27820
  • Event Risk Class
    Class 2
  • Event Number
    Z-0550-04
  • Event Initiated Date
    2003-11-24
  • Event Date Posted
    2004-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30573
  • 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
  • Reason
    Low results due to contaminant.
  • Action
    Each domestic customer will receive the recall letter by direct mailing. Foreign affiliates will be responsible for distributing letters to thier customers. Letters were sent 11/24/2003. A reply form was enclosed.

Device

Clinical Chemistry Urea Nitrogen
  • Model / Serial
    Lots: 05073HW00 04022Hw00 03041HW00
  • Distribution
    Nationwide, Mexico, Argentina, Germany, Australia, Venezuela, Puerto Rico, Singapore, New Zealand, Columbia, Canada, Hong Kong, Grand Cayman
  • Product Description
    Clinical Chemistry Urea Nitrogen
  • Manufacturer
    Abbott Laboratories Diagnostic Div

Manufacturer

Abbott Laboratories Diagnostic Div
  • Manufacturer Address
    Abbott Laboratories Diagnostic Div, 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA