PlainRecalls

Beckman Coulter, Inc.

Compiled from official public sources by the publisher.

332 recalls on record · Latest: Aug 12, 2026

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Agency notice ledger

Federal filing book Beckman Coulter, Inc. HEAVY-BOOK · SINGLE-AGENCY

#31 of 14,151 · 332 notices · 0.318% archive

  • BOOK 332 notices
  • RANK #31 of 14,151
  • SHARE 0.318% archive
  • AGENCY FDA Devices (332)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 12, 2026
  • PHOTO Windstone Medical Pac…

Nearest notice-volume peer: Windstone Medical Packaging, Inc. (4 notice gap)

Beckman Coulter, Inc. accounts for about 0.318% of the 104,423-notice archive on 332 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Beckman Coulter, Inc.'s standing among 14,151 recalling firms

Beckman Coulter, Inc. ranks 31st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Beckman Coulter, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

332 31st of 14151 higher than 14,120 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Beckman Coulter, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Beckman Coulter, Inc. holds about 0.318% of archive notices alongside 332 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 12, 2026

REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
FDA Devices Moderate Aug 12, 2026

REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
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/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
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 susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
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 lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
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 Immunoassay system, Catalog Number 81901
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 device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
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. These CellMek devices include Cassette E.
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 Access 2 Module, DxC 500i (Part Number C13252)
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 Analyzer
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; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality
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 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
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, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
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 qualitative determination of various analyte concentrations found in human body fluids
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 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
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 regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.
FDA Devices Moderate Feb 12, 2025

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

Beckman Coulter, Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (332 here — heavy-book).

Windstone Medical Packaging, Inc. 336 C & S Wholesale Grocers Inc. 338 Covidien LLC 340 Mercedes-benz 323 Whole Foods Market 318

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Windstone Medical Packaging, Inc. 336 Covidien LLC 340 Philips Medical Systems (Cleveland) Inc 315 Smiths Medical Asd, Inc. 293

Frequently Asked Questions

How many federal recall notices name Beckman Coulter, Inc.? ▼
PlainRecalls indexes 332 distinct federal recall events naming Beckman Coulter, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Beckman Coulter, Inc. sit among other recalling firms? ▼
Beckman Coulter, Inc. ranks #31 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Beckman Coulter, Inc.'s notices? ▼
FDA Devices accounts for 332 of this firm's 332 indexed notices.
What product category dominates Beckman Coulter, Inc.'s filing book? ▼
Filings for Beckman Coulter, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Beckman Coulter, Inc.: 332 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Beckman Coulter, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026