[pending] FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus s
Pending LLM rewrite. Source: FDA_DEVICE Z-1023-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
The recalled product
- Product
- FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
- Manufacturer
- Abbott Diabetes Care, Inc.
- Category
- Medical Device — Devices
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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