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Abbott issues correction for FreeStyle Libre 3 sensors over incorrect glucose readings

Abbott initiated a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors after internal testing found they might give incorrect low glucose readings. The company says the issue stems from one production line and could lead to improper treatment decisions for people with diabetes. Abbott is replacing affected sensors at no charge and has reported severe adverse events and deaths potentially associated with the issue.

Organisation involved
Abbott
Product, system or model
FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors
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This incident was imported from abbott.mediaroom.com. Our additions to it — the structured fields, the translation, the checks against other reports — are published under the same licence.

This is a record of what was reported, not a finding that anyone broke the law. If it names your organisation and you believe it is wrong, the corrections process is free and open to everyone.

Abbott issues correction for FreeStyle Libre 3 sensors over incorrect glucose readings — Wayward Fowl