Events

Recall of Device Recall AEROSET

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

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
    25621
  • Event Risk Class
    Class 2
  • Event Number
    Z-0788-03
  • Event Initiated Date
    2003-02-24
  • Event Date Posted
    2003-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26163
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Reason
    Software failure to detect error in reference solution set-up can cause inaccurate results for sodium, potassium, and chloride.
  • Action
    A Device Correction Letter was sent to all AEROSET System customers on 2/24/2003 informing them of the issue and measure they must take to minimize the risk of occurrence.

Device

Device Recall AEROSET
  • Model / Serial
    All lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to the following countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand
  • Product Description
    AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 2020, Irving TX 75038
  • Source
    USFDA