Events

Recall of AEROSET/ARCHITECT c8000 Urea Nitrogen || Models: 7D75-01; 7D75-20; 7D75-30

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
    27822
  • Event Risk Class
    Class 2
  • Event Number
    Z-0240-04
  • Event Initiated Date
    2003-11-24
  • Event Date Posted
    2003-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30588
  • 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
    Urease And Glutamic Dehydrogenase, Urea Nitrogen - Product Code CDQ
  • Reason
    False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dl bun.
  • Action
    Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.

Device

AEROSET/ARCHITECT c8000 Urea Nitrogen || Models: 7D75-01; 7D75-20; 7D75-30
  • Model / Serial
    All lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Mexico, Brazil, Germany, Singapore, Grand Cayman, Venezuela, Puerto Rico, Hong Kong, Australia, Columbia, Dominican Republic, China, Trinidad, Argentina, Canada, New Zealand, Bahamas
  • Product Description
    AEROSET/ARCHITECT c8000 Urea Nitrogen || Models: 7D75-01; 7D75-20; 7D75-30
  • 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