Events

Recall of Device Recall OneTouch Data Management Software v1.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lifescan 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
    46398
  • Event Risk Class
    Class 3
  • Event Number
    Z-1317-2008
  • Event Initiated Date
    2007-12-18
  • Event Date Posted
    2008-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67375
  • 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
    Glucose test system - Product Code NBW
  • Reason
    Meter temporarily freezes-- a software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
  • Action
    The firm sent an Urgent Recall letter to Health Care Professionals on 12/18/2007. The letter advised user to uninstall software drivers and provided options on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-9250.

Device

Device Recall OneTouch Data Management Software v1.0
  • Model / Serial
    Part Number: 021-722-01
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AL, CA, IN, IO, MA, MD, MI, MS, NE, NY, NC, OR, PA, TN, TX, UT, VT, VA, WV, and WI.
  • Product Description
    LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Manufacturer Address
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6312
  • Source
    USFDA