Has Beckman Coulter, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to Beckman Coulter, Inc.: 0 warning letters, 7 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 2026-08-26; Argus observed and indexed it on 2026-09-08.

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

Beckman Coulter Inc. — Class II recall: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5…

Name: FDA Recall Record — Beckman Coulter, Inc.
Creator: Argus HQ
Published: 2026-08-26
License: https://argushq.ai/methodology

Event date: 2026-08-26 00:00:00Z
Observed: 2026-09-08 04:20:32Z
Source ID: Z-2974-2026
Payload hash: a8c46f6febc6b9a160006d45…

Summary

a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default e… Status: Ongoing.

Entities

Beckman Coulter, Inc.

View source record ↗

Frequently asked questions

Has Beckman Coulter, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to Beckman Coulter, Inc.: 0 warning letters, 7 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 2026-08-26; Argus observed and indexed it on 2026-09-08.
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 (2026). Beckman Coulter Inc. — Class II recall: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-2974-2026

MLA

"Beckman Coulter Inc. — Class II recall: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-beckman-coulter-inc-z-2974-2026.

Chicago

Argus HQ Research. "Beckman Coulter Inc. — Class II recall: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5…." Digital Empire Holdings LLC. Accessed September 8, 2026. https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-2974-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_beckman_coulter_inc_z_2974_2026_2026,
  title = {Beckman Coulter Inc. — Class II recall: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-2974-2026},
  note = {Accessed: September 8, 2026}
}

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