Events

Recall of Device Recall OneTouch Ultra Test Strips

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
    34272
  • Event Risk Class
    Class 2
  • Event Number
    Z-0435-06
  • Event Initiated Date
    2005-11-01
  • Event Date Posted
    2006-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43399
  • 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 Oxidase, Glucose - Product Code CGA
  • Reason
    Product may be defective and may give low inaccurate glucose results.
  • Action
    Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.

Device

Device Recall OneTouch Ultra Test Strips
  • Model / Serial
    Lot number 2528640, par tnumber 020-245-07, Expiration date April 2006
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.
  • Product Description
    LifeScan OneTouch Ultra Test strips, lot number 2528640
  • Manufacturer
    Lifescan Inc

Manufacturer

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