Beckman Coulter Inc.
227 recalls on record · Latest: Feb 11, 2026
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 Aug 13, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
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 31, 2024
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
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