PlainRecalls

Beckman Coulter Inc.

Compiled from official public sources by the editorial team.

330 recalls on record · Latest: Apr 29, 2026

Beckman Coulter Inc. Recall Insight

Beckman Coulter Inc. appears on 330 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.324% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 29, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 49 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jan 15, 2025 to Apr 29, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 29, 2026

Access Total T4 Calibrator, Catalog No. 33805

FDA Devices Moderate Apr 15, 2026

MicroScan Neg MIC 3J REF C54814

FDA Devices Moderate Apr 15, 2026

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Comb…

FDA Devices Moderate Apr 1, 2026

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibili…

FDA Devices Moderate Feb 11, 2026

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lyt…

FDA Devices Moderate Feb 11, 2026

CellMek SPS Sample Preparation System, REF: C44603, with software

FDA Devices Moderate Jan 14, 2026

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

FDA Devices Moderate Jan 14, 2026

Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

FDA Devices Moderate Dec 17, 2025

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Imm…

FDA Devices Moderate Nov 26, 2025

DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic d…

FDA Devices Moderate Nov 12, 2025

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

FDA Devices Moderate Nov 12, 2025

Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

FDA Devices Moderate Nov 12, 2025

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

FDA Devices Moderate Nov 5, 2025

CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. The…

FDA Devices Moderate Oct 29, 2025

DxI 9000 Access Immunoassay Analyzer, Part Number C11137

FDA Devices Moderate Oct 29, 2025

DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Acc…

FDA Devices Moderate Oct 15, 2025

SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

FDA Devices Moderate Oct 8, 2025

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Anal…

FDA Devices Moderate Sep 24, 2025

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

FDA Devices Moderate Sep 24, 2025

UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

FDA Devices Moderate Sep 24, 2025

UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

FDA Devices Moderate Sep 24, 2025

UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

FDA Devices Moderate Aug 20, 2025

Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

FDA Devices Moderate Aug 13, 2025

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

FDA Devices Moderate Aug 13, 2025

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

FDA Devices Moderate Aug 13, 2025

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

FDA Devices Moderate Aug 13, 2025

DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

FDA Devices Moderate Aug 13, 2025

DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

FDA Devices Moderate Aug 13, 2025

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Devices Moderate Aug 13, 2025

UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100

FDA Devices Moderate Jul 30, 2025

Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

FDA Devices Moderate Jul 23, 2025

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

FDA Devices Moderate Jul 2, 2025

REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413;…

FDA Devices Moderate Jul 2, 2025

DxI 9000 Access Immunoassay Analyzer C11137

FDA Devices Moderate Jun 18, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

FDA Devices Moderate Jun 11, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

FDA Devices Moderate Jun 11, 2025

Access Testosterone assay, Catalog Number 33560

FDA Devices Moderate May 21, 2025

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 …

FDA Devices Moderate May 7, 2025

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4…

FDA Devices Moderate Apr 30, 2025

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

FDA Devices Moderate Apr 16, 2025

DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitati…

FDA Devices Moderate Apr 9, 2025

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 A…

FDA Devices Moderate Mar 26, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

FDA Devices Moderate Mar 26, 2025

Access 2 Immunoassay Analyzer, Catalog Number 81600N

FDA Devices Moderate Mar 26, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

FDA Devices Moderate Mar 19, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

FDA Devices Moderate Mar 12, 2025

Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regu…

FDA Devices Moderate Feb 12, 2025

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

FDA Devices Moderate Feb 12, 2025

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

FDA Devices Moderate Jan 15, 2025

Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (para…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Beckman Coulter Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.