Events

Recall of Life Scan One Touch Ultra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Matrix Distributors, 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
    36932
  • Event Risk Class
    Class 1
  • Event Number
    Z-0477-2007
  • Event Initiated Date
    2006-10-09
  • Event Date Posted
    2007-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49586
  • 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 NBW
  • Reason
    Counterfeit test strips (manufacturer unknown).
  • Action
    Matrix Distributors contacted by telephone those pharmacies to which they had shipped the affected lots. These call were conducted from 10/9 to 10/13/2006. A follow-up letter was issued to the pharmacies extending the recall to the user level.

Device

Life Scan One Touch Ultra

Manufacturer

Matrix Distributors, Inc.
  • Manufacturer Address
    Matrix Distributors, Inc., 110 Tices Ln, Unit 5B, E Brunswick NJ 08816-2048
  • Source
    USFDA