Events

Recall of Device Recall AxSYM, IMx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Health Products, 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
    25554
  • Event Risk Class
    Class 2
  • Event Number
    Z-0627-03
  • Event Initiated Date
    2002-12-13
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26033
  • 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
    Results lower than package insert ranges.
  • Action
    Device Recall Letters were mailed to all Abbott customers World Wide on 12/11/02. The letter instructed to check their inventory for the recalled product, discontinue use and destroy it according to their laboratory procedures. If the product was forwarded to another laboratory, please provide them with a copy of the letter.

Device

Device Recall AxSYM, IMx
  • Model / Serial
    Product list number: 9C05-10 Lot No.: 91533Q100 Exp. date: 10/20/2003
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain
  • Product Description
    AFP Control Kit distributed under the following label: || AxSYM and IMx, Abbott Laboratories USA, North || Chicago, IL 60064
  • Manufacturer
    Abbott Health Products, Inc.

Manufacturer

Abbott Health Products, Inc.
  • Manufacturer Address
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
  • Source
    USFDA