FreeStyle Libre 2 Readers may fail to activate new sensors
FreeStyle Libre 2 Readers may display an 'Incompatible Sensor' error when attempting to activate a new sensor after incomplete 14-day wear, potentially preventing new sensor activation and causing delayed glucose monitoring.
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: This Class II medical device recall involves a functional defect creating a risk of interrupted glucose monitoring for diabetic patients. No illnesses or injuries have been reported, so under the severity rubric it qualifies as 'High' under the criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Abbott Diabetes Care has recalled FreeStyle Libre 2 Readers (models REF 71951-01 and 71953-01) due to a sensor activation compatibility issue. When users attempt to start a new sensor after their previous sensor has not completed its full 14-day wear period, the reader may display an "Incompatible Sensor" error message. Users without access to the previous sensor or the FreeStyle Libre 2 mobile app may be unable to activate a new sensor, resulting in no or delayed blood glucose readings.
The recall affects 1,722,645 units distributed nationwide in the United States. Consumers experiencing this issue should contact Abbott Diabetes Care for support in resolving the incompatibility and obtaining replacement devices or guidance.
The recalled product
- Product
- FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
- sensor-incompatibility
- device-malfunction
- delayed-glucose-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lots: 71951-01/357599805005/02A289D
- 03B082D
- 02B082D
- 02B109D
- 03B251D
- 04B251D
- 01C073D
- 01C084D
- 02C087D
- 01C143D
- 03C152D
- 03C166D
- 01C174D
- 03C222D
- 01C256D
- 02C313D
- 01D018D
- 02D093D
- 02D129D
- 71953-01/357599803001/01A198D
Distribution
Distributed nationwide across the United States.
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