FDA recall record · openFDA
Beckman Coulter, Inc.
90 FDA recalls on record (2023–2026) — 90 device. 90 still ongoing.
0
Class I (most serious)
89
Class II
1
Class III
90
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versi 6
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples 4
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assem 4
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was ena 3
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failure 3
Recalls
Access Total T4 Calibrator, Catalog No. 33805 Class II 2026-03-16 COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjun Class II 2025-11-10 UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, Class II 2025-06-26 DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 Class II 2025-06-25 Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl Class II 2025-06-12 DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 Class II 2025-06-25 UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322 Class II 2025-08-13 DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 Class II 2025-06-25 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Class II 2025-03-17 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. Class II 2025-03-20 Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, Class II 2025-02-03 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 Class II 2025-04-23 CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU Class II 2025-09-08 Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio Class II 2025-11-07 Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 Class II 2025-02-27 Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit Class II 2025-11-26 Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit Class II 2025-11-26 Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer Class II 2025-10-01 MicroScan Neg MIC 3J REF C54814 Class II 2025-06-25 UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 Class II 2025-08-13 DxI 9000 Access Immunoassay Analyzer, Part Number C11137 Class II 2025-09-19 DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 Class II 2025-06-25 DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us Class II 2025-09-22 UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520 Class II 2025-08-13 REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4 Class II 2025-04-08 Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems Class II 2025-01-02 DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part Class II 2025-08-04 UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858 Class II 2025-08-13 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278 Class II 2025-02-06 Access 2 Immunoassay Analyzer, Catalog Number 81600N Class II 2025-02-05 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20 Class II 2025-04-23 UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 Class II 2025-06-25 SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only. Class II 2025-09-03 CellMek SPS Sample Preparation System, REF: C44603, with software Class II 2025-12-23 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. Class II 2025-02-05 DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i Class II 2025-09-19 DxI 9000 Access Immunoassay Analyzer C11137 Class II 2025-05-07 Access Testosterone assay, Catalog Number 33560 Class II 2025-05-05 Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 Class II 2025-07-10 Beckman Coulter DxI 9000 Access Immunoassay Analyzer Class II 2025-03-27 Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer Class II 2025-10-01 UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 Class II 2025-06-25 MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining ant Class II 2025-07-24 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Class II 2025-02-26 SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 Class II 2025-09-17 MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Class II 2025-09-08 Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int Class II 2024-11-26 Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t Class II 2024-11-18 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMM Class II 2024-07-31 Discrete photometric chemistry analyzer for clinical use. Class II 2024-06-14 DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 Class II 2024-11-13 Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Class II 2024-09-05 Access Total T4, REF 33800, IVD, thyroxine reagent assay. Class II 2024-02-08 DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic Class II 2024-04-18 Access Substrate, REF 81906, For use with the Access Immunoassay Systems Class II 2024-02-07 DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, Class II 2024-03-05 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument Class II 2024-01-03 Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 Class II 2024-05-27 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; Class II 2024-07-10 The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio Class II 2024-08-28 DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, se Class II 2024-07-12 Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. Class II 2024-06-04 DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. Class II 2024-05-22 Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It Class II 2024-02-29 Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determi Class II 2024-11-08 Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitati Class II 2024-04-18 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. Class II 2024-05-22 The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination o Class II 2024-09-30 DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis Class II 2023-04-05 Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 Class II 2023-11-21 Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 Class II 2023-12-19 iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbe Class II 2023-04-05 iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) Class II 2023-12-19 Ringed DxI Reaction Vessels (RVs) Class II 2023-06-20 UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis Class II 2023-04-05 Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL Class II 2023-04-05 iQ Waste Well Adapter, Part Number: 700-3393 Class II 2023-12-19 Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL Class II 2023-04-05 DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic Class II 2023-09-12 DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, Class II 2023-11-21 Access Thyroglobulin Calibrators Class II 2023-07-06 Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbishe Class II 2023-01-26 Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 Class II 2023-07-12 Access Hybritech p2PSA reagent, REF B03704 and REF A49752. Class II 2023-05-17 REV 2 Flowcell Capsule Spare, Part Number: C04154 Class II 2023-12-19 DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis Class II 2023-04-05 Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs. Class II 2023-03-15 COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells Class II 2023-05-31 Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL Class II 2023-04-05 Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic Class III 2024-07-16
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.