Events

Recall of Device Recall Lifescan OneTouch Ultra Meter

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
    31815
  • Event Risk Class
    Class 1
  • Event Number
    Z-1596-05
  • Event Initiated Date
    2003-11-21
  • Event Date Posted
    2005-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38552
  • 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
    Lifescan brand onetouch ultra meter - owner's booklets are missing instructions on how to set the units of measurement (uom)--mg/dl versus mmol/l. this error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dl of glucose is equal to 1 (one) mmol/l.
  • Action
    Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner''s booklet.

Device

Device Recall Lifescan OneTouch Ultra Meter
  • Model / Serial
    Includes all System Kits shipped during June 2003 until December 2003
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner''s Booklets between March 31, 2003 and October 3, 2003.
  • Product Description
    LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; || Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
  • Manufacturer
    Lifescan Inc

Manufacturer

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