Following its recall last year, the FDA has now classified the warning for the faulty CGM sensors
The US Food and Drug Administration has escalated the recall of specific Abbott FreeStyle Libre 3 and 3 Plus continuous glucose monitors to Class I, the highest level of urgency.
The recall, which impacts sensors that may provide glucose readings significantly lower than the user’s actual blood sugar level, has been linked to 860 serious injuries and seven deaths as of last month.
The company first alerted affected customers via a letter sent in November. Later, on December 2, the FDA publicly announced the recall in an ‘Early Warning’ and has now updated the alert to reflect its more severe status.
What caused the initial problem?
Abbott believes the issue has been traced to a specific production line and has since confirmed the cause and resolved it.
The company says it stems from sensors displaying glucose readings that are lower than a user’s actual blood glucose levels.
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For people with diabetes, this naturally poses a significant risk. Inaccurate low blood glucose readings could prompt unnecessary treatment decisions—such as reducing insulin or consuming additional carbohydrates. This may potentially lead to dangerous hyperglycaemia.
How to check if your CGM is affected
The recall affects specific model numbers of both the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
Users can check whether their device is impacted by visiting Abbott’s official recall site and entering their sensor’s serial number. The serial number can be found within the FreeStyle Libre app, on a dedicated reader, or on the sensor’s packaging.
If a sensor is confirmed to be part of the recall, Abbott advises users to stop using it immediately, remove it, and switch to a traditional blood glucose meter or another CGM in the meantime.
The company is offering free replacement sensors.
