Abbott Glucose Sensor Recall: Implications for Clinical Practice and Patient Safety

The FreeStyle Libre 3 sensors were recalled after internal testing showed they can report intermittently falsely low glucose values—an immediate concern because CGM-driven therapy and automated algorithms may be misled.

Internal testing identified sensor output differences under defined conditions that produced incorrect low readings. Reports cite about three million devices in the affected supply and associate the recall with multiple serious adverse events and a small number of deaths worldwide, underscoring the potential impact in high-volume clinics. Because CGM values inform insulin dosing, automated insulin-delivery logic, and urgent bedside decisions, any loss of accuracy can prompt excess carbohydrate administration, withheld insulin, or missed hyperglycemia.

It's recommended to advise patients to check whether their sensor is included in the recall and to remove any flagged device immediately. For all treatment decisions, default to capillary glucose meter checks until a replacement or confirmed fix is in place.

Instruct patients to safely dispose of recalled sensors, contact their diabetes care team for replacement planning, and keep documentation of the counseling, device identifiers, and an alternate glucose-verification plan in the medical record. Communicate any changes in sensor status to the multidisciplinary care team so remote monitoring and care coordination remain accurate.

Clinics should review upcoming sensor-change schedules, inventory for affected lots, and update remote-monitoring flags to avoid false alarms triggering automated responses. Programs that integrate CGM data with automated insulin-delivery or decision-support systems should suspend algorithmic bolus authorizations for patients with uncertain sensor status and rely on finger-stick values. Reconcile device-reported trends with recent clinical assessments and capillary verification before changing basal rates or insulin algorithms; treat suspect CGM trends as provisional until replacements or software fixes are confirmed.