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Beckman Coulter Inc. Recalls

212 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Beckman Coulter Inc..

212Total Recalls
6Critical
8.8MUnits Affected
Mar 16, 2026Most Recent
All Recalls

Every Beckman Coulter Inc. Recall

Sorted by most recent. Click any recall for full details.

212 recalls
High RiskFDA
Beckman Coulter, Inc.
Access Total T4 Calibrator, Catalog No. 33805
Medical Devices·2,068 affected·Mar 16, 2026
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Diagnostic Devices·1,272 affected·Nov 26, 2025
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Diagnostic Devices·6,457 affected·Nov 26, 2025
High RiskFDA
Beckman Coulter, Inc.
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyan...
Medical Devices·76,098 affected·Nov 10, 2025
High RiskFDA
Beckman Coulter, Inc.
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the ...
Diagnostic Devices·38,225 affected·Nov 7, 2025
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Medical Devices·80 affected·Oct 1, 2025
High RiskFDA
Beckman Coulter Inc.
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro ...
Diagnostic Devices·25 affected·Sep 22, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Diagnostic Devices·571 affected·Sep 19, 2025
High RiskFDA
Beckman Coulter, Inc.
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD an...
Medical Devices·108 affected·Sep 8, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Medical Devices·0 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Medical Devices·0 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Medical Devices·0 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Medical Devices·0 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
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 C...
Medical Devices·116 affected·Aug 4, 2025
High RiskFDA
Beckman Coulter Inc.
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Medical Devices·56,696 affected·Jun 26, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Diagnostic Devices·1 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Diagnostic Devices·177 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Diagnostic Devices·451 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter, Inc.
MicroScan Neg MIC 3J REF C54814
Medical Devices·688 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Diagnostic Devices·1 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter Inc.
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Medical Devices·496 affected·Jun 12, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Diagnostic Devices·231 affected·Apr 23, 2025
High RiskFDA
Beckman Coulter Inc.
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69...
Medical Devices·1,805 affected·Apr 8, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coul...
Diagnostic Devices·0 affected·Mar 20, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions...
Diagnostic Devices·136 affected·Mar 17, 2025
High RiskFDA
Beckman Coulter, Inc.
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Diagnostic Devices·10,000 affected·Feb 27, 2025
High RiskFDA
Beckman Coulter, Inc.
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal...
Respiratory Devices·498 affected·Feb 3, 2025
High RiskFDA
Beckman Coulter Inc.
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Diagnostic Devices·6,994 affected·Jan 2, 2025
High RiskFDA
Beckman Coulter, Inc.
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid h...
Diagnostic Devices·362 affected·Nov 26, 2024
High RiskFDA
Beckman Coulter, Inc.
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) ...
Cardiac Devices·2,109,804 affected·Nov 18, 2024
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Diagnostic Devices·245 affected·Nov 13, 2024
High RiskFDA
Beckman Coulter, Inc.
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobu...
Diagnostic Devices·465,481 affected·Sep 5, 2024
High RiskFDA
Beckman Coulter, Inc.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroi...
Diagnostic Devices·2,805 affected·Aug 28, 2024
High RiskFDA
Beckman Coulter Inc.
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemist...
Diagnostic Devices·12,102 affected·Jul 31, 2024
RecallFDA
Beckman Coulter, Inc.
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Diagnostic Devices·5,589 affected·Jul 16, 2024
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, ...
Diagnostic Devices·30 affected·Jul 12, 2024
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnos...
Diagnostic Devices·170 affected·Jul 10, 2024
High RiskFDA
Beckman Coulter, Inc.
Discrete photometric chemistry analyzer for clinical use.
Medical Devices·59 affected·Jun 14, 2024
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Medical Devices·13,565 affected·May 27, 2024
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Diagnostic Devices·116 affected·Apr 18, 2024
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative de...
Diagnostic Devices·17 affected·Mar 5, 2024
High RiskFDA
Beckman Coulter, Inc.
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Diagnostic Devices·64,009 affected·Feb 8, 2024
High RiskFDA
Beckman Coulter, Inc.
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Diagnostic Devices·725,568 affected·Feb 7, 2024
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Diagnostic Devices·61 affected·Jan 3, 2024
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Medical Devices·254 affected·Dec 19, 2023
High RiskFDA
Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-...
Medical Devices·112 affected·Dec 19, 2023
High RiskFDA
Beckman Coulter, Inc.
iQ Waste Well Adapter, Part Number: 700-3393
Medical Devices·2 affected·Dec 19, 2023
High RiskFDA
Beckman Coulter, Inc.
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Diabetes Devices·19,125 affected·Nov 21, 2023