Events

Recall of Lifescan OneTouch SureStep 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
    33121
  • Event Risk Class
    Class 2
  • Event Number
    Z-0101-06
  • Event Initiated Date
    2005-09-09
  • Event Date Posted
    2005-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41344
  • 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
    The lcd of the onetouch surestep meter may display incorrectly, resulting in missing segments on the display. this display failure may result in patients misreading the blood glucose result, or cause a delay in test interpretation, and could cause delays or mistreatment.
  • Action
    On 9/9/05, ***and 4/14/06 (expanded)***the firm notified its consumers, Health Care Professionals (HCPs), pharmacies, and direct accounts (including wholesalers and distributors) by letter and phone calls.

Device

Lifescan OneTouch SureStep Meter
  • Model / Serial
    The following are numbers (kit configurations) are affected by this recall: 010-341-18(OT SureStep system), 010-341-20 (OT SureStep System), 010-341-52 (OT SureStep starter kit), 010-411-06 (OT SureStepE Meter Warranty), 091-041-106 (OT SureStep Meter Warranty PBK).  The following lot numbers are affected: 42711002-01, 42711002-02, 42711002-03, 42731001-01, 42731001-02, 42891003-01, 42901001-01, 42901001-02, 42901001-03, 42911002-01, 42911002-02, 42911002-03, 42921002-01, 42921002-02, 42931001-01, 42931001-02, 42931001-03, 42941001-01, 42941001-02, 42941002-01, 42941002-02, 42941002-03, 42951001-01, 42951001-02, 42951001-03, 42951002-01, 42951002-02, 42951003-01, 42951003-02, 42961001-02, 42961004-01, 42971002-01, 42971002-02, 42971002-03, 42971002-04, 42971002-05, 42971004-01, 42981001-01, 42981001-02, 42981001-03, 42981001-04, 42981001-05, 42981001-06, 42991001-01, 42991001-02, 42991001-03, 43621003-01, 43631001-01, 50051004-01, 50051004-02, 50051004-03, 50061001-01, 50061001-02, 50061001-03, 50081002-01, 50081002-02, 50081002-03, 50091001-01, 50091002-02, 50101001-01, 50101001-02, 50111001-01, 50111002-01, 50121001-01, 50121001-02, 50131001-01, 50131001-02, 50141001-02, 50141001-03, 50171001-04, 50311003-03, 50311003-04, 50321002-01, 50331001-02, 50351002-01, 50351002-02, 50361005-01, 50371001-01, 50371001-02, 50471001-04, 50481001-03.  ***On 4/14/06 the recall was expanded to include meters with Serial Numbers Between L3152Rxxxxxx and L5348Rxxxxxx, 31532002-01 to 53411001-01, 888-845-8904***
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Total amount of product distributed in the U.S. is 19,177 units, to distribution centers to be distributed to retailers, Health Care Professionals, wholesalers, and mail order companies. The product was distributed throughout the United States; 29,377 were distributed to Asia, Europe and Latin America.
  • Product Description
    Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is 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