Events

Recall of Device Recall OneTouch SureStep

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
    54565
  • Event Risk Class
    Class 2
  • Event Number
    Z-2027-2010
  • Event Initiated Date
    2010-02-24
  • Event Date Posted
    2010-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88722
  • 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
    Products may provide inaccurate results at readings over 400 mg/dl.
  • Action
    The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.

Device

Device Recall OneTouch SureStep
  • Model / Serial
    Part Number 02005201 (100 count), lot numbers 2969798, 2969251, 2982369, 2983467; Part number 01035904 (50 count), lot numbers 2969795 and 2982566; Part number 02096401 (50 count mail order pack), lot numbers 2969481 and 2998193
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries of Europe, Latin America and Asia.
  • Product Description
    OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico || Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Manufacturer Address
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA