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fda_recall · device_recall · high

Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o…

Event date
2024-01-24 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-0734-2024
Payload hash
c0bfd9b180a2feef75eb17ef…

Summary

If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treat… Status: Completed.

Entities

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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 high severity by Argus HQ. FDA published the underlying record on 2024-01-24; 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 II recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-0734-2024
MLA
"Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-0734-2024.
Chicago
Argus HQ Research. "Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-0734-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_diabetes_care_inc_z_0734_2024_2024,
  title = {Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-0734-2024},
  note = {Accessed: July 23, 2026}
}

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

Abbott Diabetes Care, Inc. — Class II recall: FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used o… · Argus HQ