PlainRecalls

Beckman Coulter Inc.

222 recalls on record · Latest: Feb 11, 2026

Beckman Coulter Inc. Recall Insight

Beckman Coulter Inc. appears on 222 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.264% 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 Feb 11, 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, 49 moderate, and 1 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 31, 2024 to Feb 11, 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 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 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 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 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 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 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 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 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 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 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 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…

FDA Devices Moderate Jan 1, 2025

Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in hu…

FDA Devices Moderate Nov 6, 2024

Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody…

FDA Devices Moderate Oct 23, 2024

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems a…

FDA Devices Low Oct 23, 2024

Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

FDA Devices Moderate Oct 23, 2024

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulatin…

FDA Devices Moderate Sep 25, 2024

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrume…

FDA Devices Moderate Sep 11, 2024

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination …

FDA Devices Moderate Aug 21, 2024

Discrete photometric chemistry analyzer for clinical use.

FDA Devices Moderate Jul 31, 2024

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

FDA Devices Moderate Jul 10, 2024

DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

FDA Devices Moderate Apr 3, 2024

Access Substrate, REF 81906, For use with the Access Immunoassay Systems

FDA Devices Moderate Mar 27, 2024

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

FDA Devices Moderate Feb 14, 2024

Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

FDA Devices Moderate Feb 14, 2024

DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

FDA Devices Moderate Jan 31, 2024

Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947

FDA Devices Moderate Jan 31, 2024

iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 7…

FDA Devices Moderate Jan 31, 2024

iQ Waste Well Adapter, Part Number: 700-3393

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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