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 2026-04-29; Argus observed and indexed it on 2026-07-09.

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: Access Total T4 Calibrator, Catalog No. 33805

Name: FDA Recall Record — Beckman Coulter, Inc.
Creator: Argus HQ
Published: 2026-04-29
License: https://argushq.ai/methodology

Event date: 2026-04-29 00:00:00Z
Observed: 2026-07-09 22:52:55Z
Source ID: Z-1922-2026
Payload hash: 281e502a6d81b570a755de42…

Summary

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treat… 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 2026-04-29; Argus observed and indexed it on 2026-07-09.
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: Access Total T4 Calibrator, Catalog No. 33805. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-1922-2026

MLA

"Beckman Coulter, Inc. — Class II recall: Access Total T4 Calibrator, Catalog No. 33805." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-beckman-coulter-inc-z-1922-2026.

Chicago

Argus HQ Research. "Beckman Coulter, Inc. — Class II recall: Access Total T4 Calibrator, Catalog No. 33805." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-1922-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_beckman_coulter_inc_z_1922_2026_2026,
  title = {Beckman Coulter, Inc. — Class II recall: Access Total T4 Calibrator, Catalog No. 33805},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-beckman-coulter-inc-z-1922-2026},
  note = {Accessed: August 27, 2026}
}

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