Events

Recall of Device Recall AxSYM System Tubing Decontamination Solution

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

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
    51258
  • Event Risk Class
    Class 3
  • Event Number
    Z-2317-2009
  • Event Initiated Date
    2009-02-18
  • Event Date Posted
    2009-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79482
  • 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
    Bottle labels from lot 211974, axsym system tubing decontamination solution (list number 7b05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.
  • Action
    Abbott sent Product Recall Immediate Action Required letters dated February 18, 2009 to customers informing them of the affected product. Customers were instructed to examine their inventory and dispose all affected product. Accounts were requested to complete and fax back customer reply sheet acknowledging receipt of the letter, as well as the number of bottles destroyed, and to retain a copy of the letter for their records. For further information, contact Abbott Customer Service at 1-877-4ABBOTT.

Device

Device Recall AxSYM System Tubing Decontamination Solution
  • Model / Serial
    List 7B05-09, Lot Number: 211974, expiration date 9/30/09.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States including Puerto Rico and Argentina, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, South Korea, Thailand and Trinidad & Tobago.
  • Product Description
    AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09. || To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA