Libre 3 Plus sensors recalled over carbon build up causing low readings
Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 Plus Sensor, REF 72080-01, 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 8,062 sensors carrying UDI-DI 00357599819002, with product expiry date 01/31/2026 and the kit pack lot number 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 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 — Glucose monitor
- Affected units
- 8,062
Distribution
Part of a larger recall action
This product is one of 4 recalled by Abbott Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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