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FDA · Company announcement correction

FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors

Reason
Internal testing determined that some sensors may provide incorrect low glucose readings.
Product
FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors
Product type
Medical Devices
Date
Jan. 15, 2026
Announced by
Abbott
Brand
FreeStyle Libre
Product
FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors
Reason
Internal testing determined that some sensors may provide incorrect low glucose readings.
Product type
Medical Devices

What this record is about

A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.

A generic icon of the kind of thing the record is aboutA simplified icon of the kind of thing the record is about and the phrases of the record's own text beside it.1 The record: FreeStyle Libre 3 and 3 Plus Glucose…2 In the record's words:3 Only the kind of thing is drawn4 The record's own words are below“Internal testing determined that some sensors may provide incorrectlow glucose readings.”LABELFREESTYLE LIBRE 3 AND 3…

“Internal testing determined that some sensors may provide incorrect low glucose readings.”FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors, FDA-posted company announcement, 2026-01-15. The caption is the record's own words.

The picture shows the kind of thing the record is about (a part, a product, a package), not the product itself; the ring marks it. Nothing in it is a claim beyond the record's own words below.

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This recall among the others

  • Abbott: 5 other recalls or notices on this site in the three years before this one (from Jan. 16, 2023).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained

Source: the company's announcement, posted by the FDA on Jan. 15, 2026. Read the full announcement on FDA.gov. The announcement governs; check it and the company before acting.

Cite this record
FDA record abbott-initiates-medical-device-correction-certain-freestyle-librer-3-and-freestyle-libre-3-plus, Jan. 15, 2026. "FreeStyle Libre 3 and 3 Plus Glucose monitoring sensors." PlainRecords, https://plainrecords.com/recall/fda/abbott-initiates-medical-device-correction-certain-freestyle-librer-3-and-freestyle-libre-3-plus/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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