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Safety Report: Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings, USA

1 month ago •source fda.gov

Recall notice

Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings photo #1

United States

Abbott has initiated a voluntary medical device correction for a small number of FreeStyle Libre® 3 sensors due to sensors may provide incorrect high glucose readings. The product was distributed in the United States during the first half of May 2024.

The FreeStyle Libre 3 system includes a sensor, reader and app. This medical device correction impacts the sensor only. The FreeStyle Libre 3 reader and app are not impacted. Internal testing determined that some of the sensors from among three lots may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes and can lead to incorrect treatment decisions, such as taking insulin when not required.

This issue affects only a small subset of FreeStyle Libre 3 sensors from among those within the following three lot numbers:
- T60001948
- T60001966
- T60001969
If consumers have FreeStyle Libre 3 sensors from other lots, there is no need to take action and they can continue to use their sensors. There is no impact for users who live outside of the U.S.

How to Identify Lot or Serial Number:
If the sensor is still in the package, the lot and serial number (identified as “SN”) can be found on the bottom of the carton’s packaging. If the sensor is currently in use or may have already been used, the serial number can be displayed within the FreeStyle Libre 3 app or reader.

Consumers are instructed to conduct a fingerstick test using any blood glucose meter if they experience symptoms that do not match the sensor glucose reading or suspect the reading may be inaccurate. The built-in blood glucose meter in the FreeStyle Libre 3 reader may be used to check glucose at any time.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Abbott
Brand name: Abbott
Product recalled: FreeStyle Libre® 3 sensors
Reason of the recall: Sensors may provide incorrect high glucose readings
FDA Recall date: July 31, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-issues-voluntary-medical-device-correction-small-number-freestyle-librer-3-sensors-us

#medicaldevices #recall #us

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