Events

Recall of FreeStyle InsuLinx 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 Diabetes Care, 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
    64876
  • Event Risk Class
    Class 1
  • Event Number
    Z-1245-2013
  • Event Initiated Date
    2013-04-15
  • Event Date Posted
    2013-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117228
  • 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
    At rare, extremely high glucose levels (1024 mg/dl and above), the freestyle insulinx blood glucose meter may provide an inaccurate reading.
  • Action
    Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.

Device

FreeStyle InsuLinx Blood Glucose Monitoring System
  • Model / Serial
    Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    FreeStyle InsuLinx Blood Glucose Monitoring System: || For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. || Abbott Diabetes Care, Inc. || 1360 South Loop Road || Alameda, CA 94502 USA || The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • Manufacturer Address
    Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA