Events

Recall of OneTouch Ultra

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
    33942
  • Event Risk Class
    Class 3
  • Event Number
    Z-0272-06
  • Event Initiated Date
    2005-10-10
  • Event Date Posted
    2005-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42769
  • 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
    Users may inadvertently change units of measurement on demonstration kits of the onetouch ultra blood glucose meters.
  • Action
    A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit.

Device

OneTouch Ultra
  • Model / Serial
    Listing Number B026094, Code 90273 Kaban, all demo kits shipped between 04/08/2005 and 08/23/2005
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution
  • Product Description
    LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Manufacturer Address
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA