Events

Recall of Device Recall One Touch 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
    54382
  • Event Risk Class
    Class 2
  • Event Number
    Z-2639-2010
  • Event Initiated Date
    2010-01-07
  • Event Date Posted
    2010-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88362
  • 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
    One touch ultra test strip products may actually contain a different product, one touch select strips.
  • Action
    Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.

Device

Device Recall One Touch Ultra Test Strips
  • Model / Serial
    Part Number 020-245-32, lot number 2964512, manufactured between 09/10/2009 and 09/24/2009, distributed between 09/30/2009 and 10/27/2009.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.
  • Product Description
    One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, 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