Events

Recall of Device Recall OneTouch SureStep 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
    50471
  • Event Risk Class
    Class 2
  • Event Number
    Z-1070-2009
  • Event Initiated Date
    2008-11-25
  • Event Date Posted
    2009-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75451
  • 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
    Over the Counter Blood Glucose Test System - Product Code NBW
  • Reason
    Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
  • Action
    Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall.

Device

Device Recall OneTouch SureStep Test Strips
  • Model / Serial
    Lot codes 2802961 and 2802962
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and the Caribbean.
  • Product Description
    OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
  • Manufacturer
    Lifescan Inc

Manufacturer

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