FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings
FreeStyle Libre 3 sensors may report falsely high glucose levels, causing users to over-dose insulin and miss dangerous low blood sugar episodes. Abbott has recalled 8,174 units.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Although no deaths or injuries have been reported, the device malfunction can result in serious adverse outcomes including severe hypoglycemia, loss of consciousness, seizures, coma, and death. Class I recalls require minimum severity 4.
Plain-English summary
Abbott Diabetes Care is recalling specific lots of FreeStyle Libre 3 continuous glucose monitoring sensors due to inaccurate glucose readings. The sensors report erroneously high glucose values.
Users relying on these inaccurate readings risk miscalculating insulin doses and administering larger amounts than medically necessary. More critically, users may miss or delay recognizing hypoglycemia (low blood sugar), which is especially dangerous when onset is rapid. Undetected or delayed detection of severe hypoglycemia can result in loss of consciousness, seizures, coma, permanent neurological damage, or death.
Approximately 8,174 sensors were distributed across the United States to the following states: New Jersey, Pennsylvania, Ohio, Texas, Virginia, California, New York, Florida, Washington, Mississippi, Minnesota, and Wyoming. Multiple specific lot numbers have been identified in the recall.
The recalled product
- Product
- FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
- inaccurate-glucose-reading
- insulin-overdose-risk
- hypoglycemia-detection-failure
- device-malfunction
Distribution
Distributed in 12 states:
- CA
- FL
- MN
- MS
- NJ
- NY
- OH
- PA
- TX
- VA
- WA
- WY
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