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 2025-11-19; 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: Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalo…

Name: FDA Recall Record — Abbott Laboratories
Creator: Argus HQ
Published: 2025-11-19
License: https://argushq.ai/methodology

Event date: 2025-11-19 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-0489-2026
Payload hash: 62e73303a775ce54d9bc6ccb…

Summary

Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. 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 2025-11-19; 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 (2025). Abbott Laboratories — Class II recall: Brand Name: Alinity hq Analyzer  Product Name: Alinity hq Analyzer  Model/Catalo…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-laboratories-z-0489-2026

MLA

"Abbott Laboratories — Class II recall: Brand Name: Alinity hq Analyzer  Product Name: Alinity hq Analyzer  Model/Catalo…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-abbott-laboratories-z-0489-2026.

Chicago

Argus HQ Research. "Abbott Laboratories — Class II recall: Brand Name: Alinity hq Analyzer  Product Name: Alinity hq Analyzer  Model/Catalo…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-laboratories-z-0489-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_laboratories_z_0489_2026_2025,
  title = {Abbott Laboratories — Class II recall: Brand Name: Alinity hq Analyzer  Product Name: Alinity hq Analyzer  Model/Catalo…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-laboratories-z-0489-2026},
  note = {Accessed: July 23, 2026}
}

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