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

Yes. Argus HQ has recorded 5 total FDA actions tied to Beckman Coulter, Inc.: 0 warning letters, 5 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 2026-08-12; Argus observed and indexed it on 2026-08-19.

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: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the followi…

Name: FDA Recall Record — Beckman Coulter, Inc.
Creator: Argus HQ
Published: 2026-08-12
License: https://argushq.ai/methodology

Event date: 2026-08-12 00:00:00Z
Observed: 2026-08-19 04:20:39Z
Source ID: Z-2889-2026
Payload hash: 3ec8a6ee7575bec7421b2c66…

Summary

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." 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 5 total FDA actions tied to Beckman Coulter, Inc.: 0 warning letters, 5 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 2026-08-12; Argus observed and indexed it on 2026-08-19.
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: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the followi…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-2889-2026

MLA

"Beckman Coulter Inc. — Class II recall: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the followi…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-beckman-coulter-inc-z-2889-2026.

Chicago

Argus HQ Research. "Beckman Coulter Inc. — Class II recall: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the followi…." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-2889-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_beckman_coulter_inc_z_2889_2026_2026,
  title = {Beckman Coulter Inc. — Class II recall: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the followi…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-2889-2026},
  note = {Accessed: August 19, 2026}
}

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