Events

Recall of ACCU-CHEK ADVANTAGE TEST STRIPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS CORPORATION.

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
    13158
  • Event Risk Class
    III
  • Event Initiated Date
    2006-03-01
  • 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
    Potential for the presence of a plastic srand at the top of the test strip vial that could prevent a proper seal between the vial and the lid potentially leading to a wrong result.

Device

ACCU-CHEK ADVANTAGE TEST STRIPS
  • Model / Serial
    Model Catalog: 12030578001 (Lot serial: ALL); Model Catalog: 12030586001 (Lot serial: ALL)
  • Product Description
    ACCU-CHEK ADVANTAGE TEST STRIP
  • Manufacturer
    ROCHE DIAGNOSTICS CORPORATION

Manufacturer

ROCHE DIAGNOSTICS CORPORATION
  • Manufacturer Address
    INDIANAPOLIS
  • Source
    HC