Events

Recall of Device Recall Abbott AxSYM System Digoxin III Reagent Pack

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

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
    37904
  • Event Risk Class
    Class 2
  • Event Number
    Z-1202-2007
  • Event Initiated Date
    2007-03-30
  • Event Date Posted
    2007-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52172
  • 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
    in vitro diagnostic - Product Code KXT
  • Reason
    Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the axsym digoxin iii assay.
  • Action
    On Abbott letterhead dated March 30, 2007 - The instructions are to provide a copy of the accompanying Product Correction Letter to the laboratory manager/supervisor responsible for AxSYM Digoxin II or AxSYM Digoxin III testing. The laboratory manager/supervisor should complete the information on the letter acknowledging receipt of the product Correction Letter and Fax the Customer Reply Form, prior April 12, 2007 to Fax number 1-800-777-0051.

Device

Device Recall Abbott AxSYM System Digoxin III Reagent Pack
  • Model / Serial
    Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.
  • Product Description
    Abbott AxSYM System Digoxin III Reagent Pack
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Manufacturer Address
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA