Glucose monitoring sensors recalled over carbon build up causing low readings
Abbott Diabetes Care is recalling 1,060,723 FreeStyle Libre 3 sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The FreeStyle Libre 3 Sensor, REF 72081-01, a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System, is being recalled by Abbott Diabetes Care, Inc.
The reason given in the enforcement record is a manufacturing process issue that may cause carbon build up in the sensor, which may result in incorrect low glucose results.
The record lists 1,060,723 sensors carrying UDI-DI 00357599818005, with product expiry date 12/31/2025 and kit lot numbers recorded in the enforcement record. Distribution covered a wide range of US states. The FDA has classified the action as Class I, its most serious category.
Users should follow Abbott's instructions and check with their clinician about confirming glucose readings.
The recalled product
- Product
- FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
- Manufacturer
- Abbott Diabetes Care, Inc.
- Category
- Medical Device — Glucose monitor
- Hazard
- incorrect-results
- carbon-build-up
- glucose-monitoring
- class-i
Distribution
Distributed in 36 states:
- AK
- AL
- AZ
- CA
- CO
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- NE
- NJ
- NV
- NY
- OH
- OK
- PA
- SC
- SD
- TX
- UT
- VA
- WI
- WV
- WY
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