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- Nov 24, 202590% CONFIDENCEfrom the source
Abbott Corrects FreeStyle Libre 3 Sensors Over False Low Readings
- Abbott initiated a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors in the United States after internal testing found some may give incorrect low glucose readings[1]
- Undetected false lows over time may lead people with diabetes to eat excess carbohydrates or skip or delay insulin, which may pose serious risks including injury or death[1]
- The cause, which Abbott says it has resolved, is one production line; about 3 million U.S. sensors are involved, roughly half already expired or used, and Abbott had reports of 736 severe adverse events (57 in the U.S.) and seven deaths (none in the U.S.)[1]
- Users check their sensor serial number at FreeStyleCheck.com, stop using and dispose of affected sensors and get free replacements; Libre 3 readers, apps and other Libre sensors are not affected[1]
- The FDA issued an Early Alert on 2 December 2025 and classified the action a Class I recall, its most serious type, on 4 February 2026; as of 7 January 2026 Abbott had reported 860 serious injuries and seven deaths[4]
- The FDA warned people to stop using the affected sensors[3], and NPR reported that all seven deaths were outside the United States[2]
References 488% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]90%abbott.mediaroom.com/press-releases?item=124718abbott.mediaroom.com· Posted Sep 23, 2026· Starts Nov 24, 2025 ✓· 51% of score
Abbott's release is datelined "ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction", and the FDA[4] recall page says "On November 24, 2025, Abbott Diabetes Care sent all affected customers a letter".
- [2]85%7 deaths and hundreds of injuries are linked to faulty Abbott glucose monitorsnpr.org· Published Dec 6, 2025· 17% of score
NPR report on the correction: 3 million sensors, one production line, 736 severe injuries (57 U.S.) and seven deaths, all outside the U.S.
- [3]80%Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warnsgulfnews.com· Published Dec 4, 2025· 16% of score
AP wire story carried by Gulf News on the FDA's[4] warning to stop using the affected Libre 3 and Libre 3 Plus sensors.
- [4]92%Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensorsfda.gov· Published Dec 2, 2025· 16% of score
The FDA's recall page: Class I classification (2/4/2026), the 12/02/2025 Early Alert, affected model numbers and 860 serious injuries and seven deaths as of 7 January 2026.
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