Events

Recall of OneTouch SureStep Pro 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
    36774
  • Event Risk Class
    Class 2
  • Event Number
    Z-0453-2007
  • Event Date Posted
    2007-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49341
  • 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
    Blood Glucose test strips - Product Code CGA
  • Reason
    Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
  • Action
    The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.

Device

OneTouch SureStep Pro Test Strips
  • Model / Serial
    Lot number 2634187008, Part number 010-797-02
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.
  • Product Description
    LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package, || Distributed and Manufactured by: LifeScan, Inc., || 1000 Gibraltar Drive, Milpitas, CA 95037
  • Manufacturer
    Lifescan Inc

Manufacturer

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