Events

Recall of CONTOUR NEXT CONTROL SOLUTION (LOW)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYER 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
    84943
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-25
  • 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
    1.Control result not marked as a control test: bayer healthcare has received user reports on contour next control test results that are higher than the control range published on the packaging of contour next test strips and not recognized as control tests by the meter. all lots of contour next control solution (levels low normal and high) are affected. 2.Control result outside of control range: another issue may affect any control solution lots when used with contour next test strip lots with expiration dates through november 2016. due to unforeseen material variation lots of contour next control solution may give control test results that are outside of the assigned control range as published on the packaging of contour next test strips. these control results are properly marked as control tests by the meter therefore this issue does not impact insulin pumps.

Device

CONTOUR NEXT CONTROL SOLUTION (LOW)
  • Model / Serial
    Model Catalog: 7323 (Lot serial: All lots); Model Catalog: 7325 (Lot serial: All lots); Model Catalog: 7324 (Lot serial: All lots)
  • Product Description
    CONTOUR NEXT CONTROL SOLUTION (LOW)
  • Manufacturer
    BAYER INC.

Manufacturer

BAYER INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    HC