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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 8,174
Distribution
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