Events

Recall of ONETOUCH ULTRA TEST STRIPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON 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
    33407
  • Event Risk Class
    II
  • Event Initiated Date
    2007-04-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A small number of onetouch ultra test strip vials may contain a hole on the side. this damage vial can affect the test strips and lead to error messages or blood glucose results that are too high or low.

Device

ONETOUCH ULTRA TEST STRIPS
  • Model / Serial
    Model Catalog: 020-384 (Lot serial: 2691469); Model Catalog: 020-384 (Lot serial: 2674773); Model Catalog: 020-384 (Lot serial: 2670429); Model Catalog: 020-384 (Lot serial: 2670178); Model Catalog: 020-384 (Lot serial: 2667717); Model Catalog: 020-384 (Lot serial: 2665711); Model Catalog: 020-384 (Lot serial: 2665710); Model Catalog: 020-384 (Lot serial: 2665709); Model Catalog: 020-384 (Lot serial: 2665031); Model Catalog: 020-384 (Lot serial: 2665030); Model Catalog: 020-384 (Lot serial: 2665029); Model Catalog: 020-384 (Lot serial: 2646779); Model Catalog: 020-384 (Lot serial: 2660597); Model Catalog: 020-384 (Lot serial: 2655754); Model Catalog: 020-384 (Lot serial: 2653512); Model Catalog: 020-384 (Lot serial: 2653511); Model Catalog: 020-384 (Lot serial: 2650896); Model Catalog: 020-384 (Lot serial: 2650512); Model Catalog: 020-384 (Lot serial: 2650511); Model Catalog: 020-384 (Lot serial: 2649278); Model Catalog: 020-384 (Lot serial: 2649224); Model Catalog: 020-384 (Lot serial: 2648992); Model Catal
  • Product Description
    ONETOUCH ULTRA TEST STRIPS
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.