Has Abbott Laboratories had other FDA enforcement actions?

Yes. Argus HQ has recorded 15 total FDA actions tied to Abbott Laboratories: 0 warning letters, 15 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 2024-01-03; 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 · high

Abbott Laboratories — Class II recall: Alinity ci-series System Control Module, REF: 03R70-01

Name: FDA Recall Record — Abbott Laboratories
Creator: Argus HQ
Published: 2024-01-03
License: https://argushq.ai/methodology

Event date: 2024-01-03 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-0613-2024
Payload hash: b7006bf001c8f67daf4262d7…

Summary

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assig… Status: Ongoing.

Entities

Abbott Laboratories

View source record ↗

Frequently asked questions

Has Abbott Laboratories had other FDA enforcement actions?: Yes. Argus HQ has recorded 15 total FDA actions tied to Abbott Laboratories: 0 warning letters, 15 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 2024-01-03; 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 Laboratories — Class II recall: Alinity ci-series System Control Module, REF: 03R70-01. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-laboratories-z-0613-2024

MLA

"Abbott Laboratories — Class II recall: Alinity ci-series System Control Module, REF: 03R70-01." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-abbott-laboratories-z-0613-2024.

Chicago

Argus HQ Research. "Abbott Laboratories — Class II recall: Alinity ci-series System Control Module, REF: 03R70-01." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-laboratories-z-0613-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_laboratories_z_0613_2024_2024,
  title = {Abbott Laboratories — Class II recall: Alinity ci-series System Control Module, REF: 03R70-01},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-laboratories-z-0613-2024},
  note = {Accessed: July 23, 2026}
}

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