Events

Recall of Device Recall FreeStyle Blood Glucose Monitoring System

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

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
    33301
  • Event Risk Class
    Class 1
  • Event Number
    Z-0054-06
  • Event Initiated Date
    2005-06-07
  • Event Date Posted
    2005-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41682
  • 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
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Reason
    User may inadvertently change the units of measure from mg/dl to mmol/l and the blood glucose results could be misinterpreted. this may lead to under treatment and potential for hyperglycemia.
  • Action
    The firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.

Device

Device Recall FreeStyle Blood Glucose Monitoring System
  • Model / Serial
    For lot numbers beginning with A, B, C, D, G, H, K, and M, all lot numbers are included. All lot numbers from V-G157-31584 and below are included, and also all lot numbers Y-G018-32983 and below are included in the recall.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.
  • Product Description
    FreeStyle Blood Glucose Monitoring System; || Recalling Firm/Manufacturer: || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
    Abbott Laboratories Medisense Products

Manufacturer

Abbott Laboratories Medisense Products
  • Manufacturer Address
    Abbott Laboratories Medisense Products, 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA