ClearanceBrief
Company · US

Beckman Coulter Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.

279510(k) clearances (6 in 12 months)
648recalls (23 in 12 months)
486recalls that name a 510(k)

Product codes

CodeDeviceRecords
GKZCounter, Differential Cell151
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use147
LTTPanels, Test, Susceptibility, Antimicrobial23
JQPCalculator/Data Processing Module, For Clinical Use21
KQOAutomated Urinalysis System18
MMIImmunoassay Method, Troponin Subunit16
CEMElectrode, Ion Specific, Potassium15
JWYManual Antimicrobial Susceptibility Test Systems14
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)13
JISCalibrator, Primary12
JITCalibrator, Secondary12
OYEFlow Cytometric Reagents And Accessories.12
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems11
MSWSystem, Test, Thyroglobulin11
JPKMixture, Hematology Quality Control10
CGRRadioimmunoassay, Cortisol9
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)8
CGNAcid, Folic, Radioimmunoassay8
JLWRadioimmunoassay, Thyroid-Stimulating Hormone8
JQWStation, Pipetting And Diluting, For Clinical Use8

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 21, 2026K262109Access NT-proBNP
Beckman Coulter, Inc.
NBC
Mar 24, 2026K252169Access BNP II
Beckman Coulter, Inc.
NBC
Mar 13, 2026K254059Access anti-HBc IgM
Beckman Coulter, Inc.
SEI
Feb 19, 2026K253687Access anti-HBc Total
Beckman Coulter, Inc.
SEI
Jan 27, 2026K251995Access anti-HAV IgM
Beckman Coulter, Inc.
LOL
Nov 17, 2025K250588Access Rubella IgG
Beckman Coulter, Inc.
LFX
Sep 10, 2025K252580iQ200 Series
Beckman Coulter, Inc.
LKM
Sep 9, 2025K243846Access anti-HAV
Beckman Coulter, Inc.
LOL
Aug 20, 2025K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
Beckman Coulter, Inc.
LTT
Aug 15, 2025K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
Beckman Coulter, Inc.
LTT
Aug 1, 2025K243483Access hsTnI
Beckman Coulter, Inc.
MMI
Jul 18, 2025K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
Beckman Coulter, Inc.
LTT
Jun 16, 2025K242870Access hsTnI
Beckman Coulter, Inc.
MMI
Mar 28, 2025K242022Access Toxo IgG
Beckman Coulter, Inc.
LGD
Mar 5, 2025K242190Access Cortisol; DxC 500i Clinical Analyzer
Beckman Coulter, Inc.
CGR
Oct 11, 2024K242095Access Toxo IgM II
Beckman Coulter, Inc.
LGD
Sep 6, 2024K241427Access Syphilis
Beckman Coulter, Inc.
LIP
Aug 9, 2024K240469Access TPO Antibody
Beckman Coulter, Inc.
JZO
Jul 5, 2024K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniC
Beckman Coulter, Inc.
GKZ
Jul 3, 2024K240996Access Thyroglobulin Antibody II
Beckman Coulter, Inc.
JNL
Jul 3, 2024K240987Access sTfR
Beckman Coulter, Inc.
DDG
Jun 28, 2024K240927Access Thyroglobulin
Beckman Coulter, Inc.
MSW
Jun 7, 2024K241423Access Thyroglobulin
Beckman Coulter, Inc.
MSW
May 10, 2024K240479Access OV Monitor
Beckman Coulter, Inc.
LTK
May 9, 2024K240403Access BR Monitor
Beckman Coulter, Inc.
MOI
May 3, 2024K240800Access Intrinsic Factor Ab
Beckman Coulter, Inc.
LIG
Apr 22, 2024K240182Access EPO
Beckman Coulter, Inc.
GGT
Apr 15, 2024K232904Access Ostase
Beckman Coulter
CIN
Apr 12, 2024K232164Access NT-proBNP
Beckman Coulter, Inc.
NBC
Mar 20, 2024K234052Access Ferritin
Beckman Coulter, Inc.
JMG
Mar 6, 2024K240273Access Free T4
Beckman Coulter, Inc.
CEC
Mar 1, 2024K232791Access Intact PTH
Beckman Coulter, Inc.
CEW
Feb 16, 2024K234005Access CK-MB
Beckman Coulter, Inc.
JHX
Feb 8, 2024K233480Access SHBG
Beckman Coulter, Inc.
CDZ
Dec 18, 2023K222881Access hsTnI
Beckman Coulter, Inc.
MMI
Dec 4, 2023K230648Access hsTnI
Beckman Coulter, Inc.
MMI
Nov 22, 2023K232600DxFLEX Flow Cytometer; ClearLLab 10C Panels
Beckman Coulter, Inc.
OYE
Sep 26, 2023K213517Access Thyroglobulin Antibody II
Beckman Coulter, Inc.
JZO
Sep 22, 2023K223921Access CEA
Beckman Coulter, Inc.
DHX
Sep 18, 2023K231832Access Myoglobin
Beckman Coulter, Inc.
DDR
Sep 15, 2023K220972Access Thyroglobulin
Beckman Coulter, Inc.
MSW
Aug 23, 2023K223590Access Folate Assay
Beckman Coulter, Inc.
CGN
Apr 26, 2023K222996Access PCT
Beckman Coulter, Inc.
PTF
Apr 5, 2023K221493MicroScan Prompt Inoculation System-D
Beckman Coulter, Inc.
LIE
Feb 8, 2023K223038Access Cortisol
Beckman Coulter, Inc.
CGR
Feb 3, 2023K223679Access AMH
Beckman Coulter, Inc.
PQO
Jan 19, 2023K223503Access 25(OH) Vitamin D Total
Beckman Coulter, Inc.
MRG
Jan 13, 2023K223405Access Testosterone
Beckman Coulter, Inc.
CDZ
Dec 27, 2022K221990Access Total ßhCG (5th IS)
Beckman Coulter, Inc.
DHA
Dec 23, 2022K223289Access Vitamin B12
Beckman Coulter, Inc.
CDD

Newest 50 of 279.

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 21, 2026Beckman Coulter, Inc.
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468),
Open, Classified		 JQCNone listed
Oct 21, 2026Beckman Coulter, Inc.
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468),
Open, Classified		 JQCNone listed
Oct 15, 2026Beckman Coulter, Inc.
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B4899
Open, Classified		 KQOK022774
K210127 +1
Oct 15, 2026Beckman Coulter, Inc.
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Open, Classified		 KQOK022774
K210127 +1
Oct 2, 2026Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Open, Classified		 JJEK220977
Oct 2, 2026Beckman Coulter Inc.
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
Open, Classified		 JJEK242190
Aug 17, 2026Beckman Coulter Inc.
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 Analyze
Open, Classified		 JJEK220977
Aug 17, 2026Beckman Coulter Inc.
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;
Open, Classified		 JJEK242190
Aug 5, 2026Beckman Coulter Inc.
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 - B1018-2
Open, Classified		 LONK201405
Aug 5, 2026Beckman Coulter Inc.
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 Instr
Open, Classified		 LONK201405
Apr 22, 2026Beckman Coulter, Inc.
Access Total T4 Calibrator, Catalog No. 33805
Open, Classified		 KLIK023369
Apr 8, 2026Beckman Coulter, Inc.
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 Panel
Open, Classified		 LTTNone listed
Apr 3, 2026Beckman Coulter, Inc.
MicroScan Neg MIC 3J REF C54814
Open, Classified		 LTTNone listed
Mar 20, 2026Beckman Coulter, Inc.
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 aerob
Open, Classified		 LTTK202343
Feb 2, 2026Beckman Coulter, Inc.
CellMek SPS Sample Preparation System, REF: C44603, with software
Open, Classified		 PERNone listed
Jan 30, 2026Beckman Coulter, Inc.
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 Un
Open, Classified		 GIFNone listed
Jan 6, 2026Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Open, Classified		 JJEK121790
Jan 6, 2026Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Open, Classified		 JJEK121790
Dec 9, 2025Beckman Coulter, Inc.
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
Open, Classified		 JJEK121214
Nov 18, 2025Beckman 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 device for immunophenotyping up to ten fluorescent dete
Open, Classified		 OYEK232600
Nov 6, 2025Beckman Coulter Inc.
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Open, Classified		 MRRNone listed
Nov 4, 2025Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Open, Classified		 JJEK121790
Nov 4, 2025Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Open, Classified		 JJEK121790
Oct 30, 2025Beckman Coulter, Inc.
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.
Open, Classified		 PERNone listed
Oct 21, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Open, Classified		 JLWK221225
Oct 21, 2025Beckman Coulter, Inc.
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)
Open, Classified		 CGRK242190
Oct 8, 2025Beckman Coulter Inc.
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Open, Classified		 CEONone listed
Oct 2, 2025Beckman 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 Clinical Analyzer
Open, Classified		 CGRK242190
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Open, Classified		 GKZK120771
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Open, Classified		 GKZK193124
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Open, Classified		 GKZK240252
Sep 17, 2025Beckman Coulter Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Open, Classified		 GKZK240252
Aug 13, 2025Beckman Coulter, Inc.
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Open, Classified		 MSWK031269
Aug 5, 2025Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Open, Classified		 JJEK023764
Aug 5, 2025Beckman Coulter, Inc.
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Open, Classified		 JJEK023764
Aug 4, 2025Beckman Coulter Inc.
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Open, Classified		 JMOK041793
Jul 21, 2025Beckman Coulter Inc.
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Open, Classified		 CGFK935013
Jul 11, 2025Beckman Coulter, Inc.
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Completed		 CDDK955436
Jun 25, 2025Beckman Coulter Inc.
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 REMI
Open, Classified		 JQPNone listed
Jun 20, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer C11137
Open, Classified		 JJEK221225
Jun 6, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Open, Classified		 JLWK221225
Jun 5, 2025Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Open, Classified		 JLWK221225
Jun 2, 2025Beckman Coulter, Inc.
Access Testosterone assay, Catalog Number 33560
Open, Classified		 CDZK223405
May 15, 2025Beckman Coulter Inc.
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 chemistr
Open, Classified		 JJEK220977
Apr 25, 2025Beckman Coulter Inc.
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 A
Open, Classified		 JJEK220977
Apr 24, 2025Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Open, Classified		 JJEK221225

Newest 50 of 648.

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