FDA action counts
| Total FDA actions | 3 |
|---|---|
| Warning letters | 0 |
| Recalls | 3 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | April 29, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Beckman Coulter, Inc. has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.
Enforcement history
On 2026-04-15, Argus HQ recorded a FDA recall for Beckman Coulter, Inc., rated "high" severity in Argus HQ's classification: Beckman Coulter, Inc. — Class II recall: MicroScan Neg MIC 3J REF C54814 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-15, Argus HQ recorded a FDA recall for Beckman Coulter, Inc., rated "high" severity in Argus HQ's classification: Beckman Coulter, Inc. — Class II recall: MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Beckman Coulter, Inc., rated "high" severity in Argus HQ's classification: Beckman Coulter, Inc. — Class II recall: Access Total T4 Calibrator, Catalog No. 33805 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Beckman Coulter, Inc. has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Frequently asked questions
- Has Beckman Coulter, Inc. had product recalls?
- Yes, 3 recalls on file. See the full history below for each one.
- Is this FDA enforcement data for Beckman Coulter, Inc. official?
- Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
- How many FDA actions has Beckman Coulter, Inc. had?
- Argus HQ has recorded 3 FDA events for Beckman Coulter, Inc.: 0 warning letters, 3 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- What is the most recent FDA action against Beckman Coulter, Inc.?
- The most recent FDA event Argus HQ has on file for Beckman Coulter, Inc. is dated 2026-04-29, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
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Related enforcement actions
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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.
Argus HQ Research (2026). FDA Actions Against Beckman Coulter, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/company/beckman-coulter-inc
"FDA Actions Against Beckman Coulter, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/beckman-coulter-inc.
Argus HQ Research. "FDA Actions Against Beckman Coulter, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/beckman-coulter-inc.
@misc{argushq_argushq_ai_company_beckman_coulter_inc_2026,
title = {FDA Actions Against Beckman Coulter, Inc.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/beckman-coulter-inc},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗