Has Abbott Diabetes Care, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 10 total FDA actions tied to Abbott Diabetes Care, Inc.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2024-09-04; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · critical

Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Con…

Name: FDA Recall Record — Abbott Diabetes Care, Inc.
Creator: Argus HQ
Published: 2024-09-04
License: https://argushq.ai/methodology

Event date: 2024-09-04 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2692-2024
Payload hash: a6626a6650abe64760aa2e65…

Summary

Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values… Status: Ongoing.

Entities

Abbott Diabetes Care, Inc.

View source record ↗

Frequently asked questions

Has Abbott Diabetes Care, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 10 total FDA actions tied to Abbott Diabetes Care, Inc.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2024-09-04; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2024). Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Con…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2692-2024

MLA

"Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Con…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2692-2024.

Chicago

Argus HQ Research. "Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Con…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2692-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_diabetes_care_inc_z_2692_2024_2024,
  title = {Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Con…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-2692-2024},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.