Events

Safety Alert for LifeScan OneTouch Select Control Solution

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by LifeScan.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-02-28
  • Event Date Posted
    2013-02-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130228a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: lifescan onetouch select control solution it has come to our attention that medical device manufacturer, lifescan, has initiated a field safety corrective action concerning onetouch select control solution. the affected lot numbers are 2aa1d01 and 2aa2d02. lifescan is voluntarily removing and replacing two lots of onetouch select control solution distributed in russia, ukraine and republic of moldova. the purpose of control solution testing is to confirm that the meter and test strips are working together correctly as a system. the lots of control solution are being replaced because they may not provide an “in range” control test result when used with onetouch select test strips, even though the system is working correctly. as the meter’s user guide and control solution instructions for use state, an out of range control solution test result may mean the meter system is not working properly. this may lead to a delay further blood sugar testing. this issue applies to control solution test results only. the accuracy of patient blood sugar test results is not affected. the manufacturer advises users to immediately discontinue use of the affected products and contact their supplier for product replacement. it also advises users that if having control solution from the affected lots, they may continue to use the blood glucose system while waiting for replacement. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 february 2013.

Device

LifeScan OneTouch Select Control Solution
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: LifeScan OneTouch Select Control Solution
  • Manufacturer
    LifeScan

Manufacturer

LifeScan