Events

Recall of Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

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
    28041
  • Event Risk Class
    Class 2
  • Event Number
    Z-0355-04
  • Event Initiated Date
    2003-12-22
  • Event Date Posted
    2004-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31093
  • 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
    Photometric Method, Magnesium - Product Code JGJ
  • Reason
    Complaints that instructions for use were not clear.
  • Action
    Firm sent customer letters dated 12/22/2003 which included updated instructions for use.

Device

Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
  • Model / Serial
    This is not a lot specific issue.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to Mexico, Brazil, Sinagapore, Venezuela, Puerto Rico, Hong Kong, Colombia, Dominican Republic, Australia, Ecuador, Canada, New Zealand, Argentina, Germany, Bahamas, Grand Cayman, El Salvador.
  • Product Description
    Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
  • 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