Beckman Coulter, Inc.
Beckman Coulter, Inc. holds FDA 510(k) medical device clearances, first cleared 1993, most recent 2026, with 334 FDA device recalls on record.
Top product codes for Beckman Coulter, Inc.
FDA recalls by Beckman Coulter, Inc.
10 most recent of 334- Z-2974-2026 — Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
- Z-2973-2026 — Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
- Z-2889-2026 — 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
- Z-2888-2026 — 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
- Z-1922-2026 — Access Total T4 Calibrator, Catalog No. 33805
- Z-1235-2026 — CellMek SPS Sample Preparation System, REF: C44603, with software
- Z-1025-2026 — Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
- Z-1026-2026 — Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
- Z-1221-2026 — 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.
- Z-0889-2026 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Beckman Coulter, Inc.
1–100 of 270- K252169 — Access BNP II
- K254059 — Access anti-HBc IgM
- K253687 — Access anti-HBc Total
- K251995 — Access anti-HAV IgM
- K250588 — Access Rubella IgG
- K252580 — iQ200 Series
- K243846 — Access anti-HAV
- K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- K243483 — Access hsTnI
- K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
- K242870 — Access hsTnI
- K242022 — Access Toxo IgG
- K242190 — Access Cortisol; DxC 500i Clinical Analyzer
- K242095 — Access Toxo IgM II
- K241427 — Access Syphilis
- K240469 — Access TPO Antibody
- K240252 — UniCel DxH 900 Coulter Cellular Analysis System +2 more
- K240987 — Access sTfR
- K240996 — Access Thyroglobulin Antibody II
- K240927 — Access Thyroglobulin
- K241423 — Access Thyroglobulin
- K240479 — Access OV Monitor
- K240403 — Access BR Monitor
- K240800 — Access Intrinsic Factor Ab
- K240182 — Access EPO
- K232164 — Access NT-proBNP
- K234052 — Access Ferritin
- K240273 — Access Free T4
- K232791 — Access Intact PTH
- K234005 — Access CK-MB
- K233480 — Access SHBG
- K222881 — Access hsTnI
- K230648 — Access hsTnI
- K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels
- K213517 — Access Thyroglobulin Antibody II
- K223921 — Access CEA
- K231832 — Access Myoglobin
- K220972 — Access Thyroglobulin
- K223590 — Access Folate Assay
- K222996 — Access PCT
- K221493 — MicroScan Prompt Inoculation System-D
- K223038 — Access Cortisol
- K223679 — Access AMH
- K223503 — Access 25(OH) Vitamin D Total
- K223405 — Access Testosterone
- K221990 — Access Total ßhCG (5th IS)
- K223289 — Access Vitamin B12
- K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
- K220178 — Total Immunoglobulin E (IgE)
- K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- K202423 — MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
- K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
- K201405 — LabPro Data Management System
- K201423 — MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
- K193536 — MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
- K193358 — MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
- K192271 — Access PCT, Access PCT Calibrators
- K192355 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
- K190109 — MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
- K183127 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
- K172787 — Access hsTnl
- K172783 — Access hs Tnl
- K172337 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
- K172912 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)
- K172255 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
- K170524 — Access AMH
- K162740 — MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
- K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
- K161837 — ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
- K162414 — UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
- K153651 — Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
- K152346 — MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
- K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
- K142985 — UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
- K142373 — Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
- K142362 — Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
- K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
- K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
- K140829 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
- K131189 — UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
- K130122 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
- K130020 — ACCESS TOTAL BHCG (5TH IS)
- K121790 — ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- K130373 — NAVIOS FLOW CYTOMETER SYSTEM
- K121445 — TETRACHROME REAGENTS AND TETRACXP SYSTEM
- K130253 — TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
- K121214 — ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
- K120771 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K120199 — GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
- K121492 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
- K112933 — ACCESS THYROGLOBULIN ANITBODY
- K112412 — AU5800(R) CHEMISTRY ANALYZER
- K112603 — ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
- K111952 — ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
- K110251 — SYNCHRON MULTI CALIBRATOR
- K110413 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
- K103842 — UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
- K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
- K100790 — COULTER LIN-X LINEARITY CONTROL, MODEL A81196
Data sourced from openFDA. This site is unofficial and independent of the FDA.