FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors. Internal testing determined that some sensors may provide incorrect low glucose readings.
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Manufacturer & model: Device name, model or catalog number from its label or packaging. Serial, lot or UDI: The identifiers specified in the notice; retain packaging where possible. Version & care records: Software version when relevant, or an implant card and clinician’s records.
Read the medical devices identification guideWhy this notice was issued
Internal testing determined that some sensors may provide incorrect low glucose readings.
Official action
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Read the full official instructionsProduct & source details
- Product
- FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors
- Brand or manufacturer
- FreeStyle Libre
- Source
- FDA
- Notice type
- Safety alert
- Category
- Medical devices