Voluntary medical device correction: FreeStyle Libre 3 (Abbott – August)

Sep. 2024Pharmacy Updates

Abbott has announced a medical device correction for three lots of FreeStyle Libre 3 sensors, distributed in the United States during the first half of May 2024. The FreeStyle Libre 3 reader and app are not affected. FreeStyle Libre 3 sensors are used to monitor blood glucose levels as part of the FreeStyle Libre system. The FreeStyle Libre 3 system includes a sensor, reader and app. This medical device correction impacts the sensor only.

This product is being corrected because some of the sensors from these lots may give incorrect high glucose readings. This can lead to unexpected side effects of low glucose, such as sweating, dizziness, headache, tiredness, and rapid heartbeat. These can be signs of life-threatening low glucose. It can also lead to incorrect treatment decisions, such as taking insulin when not required.

The lot numbers that are part of this medical device correction are below:

    • T60001948
    • T60001966
    • T60001969
      • If your device lot number is listed above, visit

FreeStyleConfirm.com

      and enter your sensor serial number to determine if your sensor is affected by this medical device correction. Instructions for locating the serial number can also be found at

FreeStyleConfirm.com

      If your sensor is affected, enter your contact information so Abbott can send you a replacement sensor at no charge.
      If you have symptoms or think your glucose reading may be incorrect, you should complete a fingerstick test using any blood glucose meter. The built-in blood glucose meter in the FreeStyle Libre 3 reader may be used to check glucose at any time.

To learn more about this recall, you can take one or more of the steps below.

    • Talk to your doctor or pharmacist.
    • Call Abbott at 1-833-815-4273. TTY users should call 711. Help is available seven days a week from 8 a.m. to 8 p.m. ET.
    • Visit the FDA website.

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