Data / Medical devices / United States / Beckman Coulter, Inc.

Beckman Coulter, Inc.: FDA-registered device maker in Chaska, MN, United States, 78 510(k) clearances and 4 PMA approvals

Name: Beckman Coulter, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Beckman Coulter, Inc. is registered with the FDA (registration 2122870) in Chaska, MN, United States. It lists 69 device types. The FDA files 78 510(k) clearances and 4 PMA approvals under its listings, the newest dated March 24, 2026. 43 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Beckman Coulter, Inc.

FDA registration number: 2122870
Address: 1000 Lake Hazeltine DR., Chaska, MN, United States, 55318
Owner or operator: BECKMAN COULTER, INC. (2050012)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
First device listed: December 14, 1977
Registered through: 2026
Brand names listed: 442831 PVT 2, 472055 PVT 5, 442830 PVT 3, 445865 SYNCHRON Systems Wash Concentrate II, 445967 SYNCHRON CX Systems Antifoam, 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2, 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3, 447060 IMMAGE Immunochemistry Systems Wash Solution, 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4, 447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1 and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Contract manufacturer	accessdata.fda.gov
Acid, Folic, Radioimmunoassay	CGN	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission	PTF	2	Manufacturer	accessdata.fda.gov
Assay, Erythropoietin	GGT	2	Manufacturer	accessdata.fda.gov
Automated Urinalysis System	KQO	1	Contract manufacturer, Manufacturer for export	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Contract manufacturer	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Contract manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Counter, Cell, Automated (Particle Counter)	GKL	2	Contract manufacturer	accessdata.fda.gov
Counter, Urine Particle	LKM	2	Contract manufacturer	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Contract manufacturer	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Contract manufacturer	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Contract manufacturer	accessdata.fda.gov
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	CIN	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digoxin	KXT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Inhibin-A	NDR	1	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Specification developer	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Manufacturer	accessdata.fda.gov
Immunochemical, Thyroglobulin Autoantibody	JNL	2	Manufacturer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Contract manufacturer	accessdata.fda.gov
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	LOK	3	Manufacturer	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Contract manufacturer	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Contract manufacturer	accessdata.fda.gov
P2psa	OYA	3	Manufacturer	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Specification developer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Manufacturer	accessdata.fda.gov
Radioassay, Intrinsic Factor Blocking Antibody	LIG	2	Manufacturer	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), Ferritin	JMG	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Cortisol	CGR	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estriol	CGI	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroxine-Binding Globulin	CEE	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Contract manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Manufacturer	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Specification developer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Manufacturer	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Manufacturer	accessdata.fda.gov
System, Test, Thyroglobulin	MSW	2	Manufacturer	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Contract manufacturer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Manufacturer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Manufacturer	accessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	MTG	3	Manufacturer	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Contract manufacturer	accessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	MTF	3	Manufacturer	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 24, 2026	K252169	Access BNP II	NBC	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
November 17, 2025	K250588	Access Rubella IgG	LFX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
March 28, 2025	K242022	Access Toxo IgG	LGD	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
March 5, 2025	K242190	Access Cortisol; DxC 500i Clinical Analyzer	CGR	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
October 11, 2024	K242095	Access Toxo IgM II	LGD	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
September 6, 2024	K241427	Access Syphilis	LIP	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
July 3, 2024	K240996	Access Thyroglobulin Antibody II	JNL	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
July 3, 2024	K240987	Access sTfR	DDG	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
June 28, 2024	K240927	Access Thyroglobulin	MSW	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
May 10, 2024	K240479	Access OV Monitor	LTK	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
May 9, 2024	K240403	Access BR Monitor	MOI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
May 3, 2024	K240800	Access Intrinsic Factor Ab	LIG	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
April 22, 2024	K240182	Access EPO	GGT	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
April 15, 2024	K232904	Access Ostase	CIN	Substantially Equivalent	Beckman Coulter	accessdata.fda.gov
April 12, 2024	K232164	Access NT-proBNP	NBC	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
March 20, 2024	K234052	Access Ferritin	JMG	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
March 6, 2024	K240273	Access Free T4	CEC	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
February 16, 2024	K234005	Access CK-MB	JHX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
February 8, 2024	K233480	Access SHBG	CDZ	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 18, 2023	K222881	Access hsTnI	MMI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 4, 2023	K230648	Access hsTnI	MMI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
September 26, 2023	K213517	Access Thyroglobulin Antibody II	JZO	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
September 22, 2023	K223921	Access CEA	DHX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
September 18, 2023	K231832	Access Myoglobin	DDR	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
September 15, 2023	K220972	Access Thyroglobulin	MSW	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
August 23, 2023	K223590	Access Folate Assay	CGN	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
April 26, 2023	K222996	Access PCT	PTF	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
February 8, 2023	K223038	Access Cortisol	CGR	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
January 13, 2023	K223405	Access Testosterone	CDZ	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 27, 2022	K221990	Access Total ßhCG (5th IS)	DHA	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 23, 2022	K223289	Access Vitamin B12	CDD	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
November 10, 2022	K221225	Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer	JLW	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
November 26, 2019	K192271	Access PCT, Access PCT Calibrators	PTF	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
June 12, 2018	K172783	Access hs Tnl	MMI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
August 18, 2016	K153651	Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems	JLW	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
October 1, 2013	K130020	ACCESS TOTAL BHCG (5TH IS)	DHA	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
September 25, 2013	K121790	ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM	MMI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
June 14, 2013	K121214	ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM	MMI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 27, 2011	K112933	ACCESS THYROGLOBULIN ANITBODY	JNL	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
November 4, 2011	K112603	ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS	JJX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
August 19, 2011	K111952	ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033	JIT	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
August 27, 2009	K083867	ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND	CDZ	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
February 20, 2009	K080481	ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS	DDR	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
August 11, 2008	K080634	ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495	DDG	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
May 23, 2008	K080869	ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC	LGD	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
March 19, 2008	K080166	ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545	JIT	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
October 26, 2007	K072612	ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647	MOI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
February 1, 2007	K070144	INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS	JIT	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
October 6, 2006	K052223	ACCESS EPO ASSAY	GGT	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
June 2, 2006	K061282	ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585	JIT	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
April 21, 2006	K060774	FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208	CGN	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
January 23, 2006	K052789	TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200	NBC	Substantially Equivalent	Biosite Incorporated	accessdata.fda.gov
August 19, 2005	K052082	FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020	JMG	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
February 9, 2005	K050202	CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS	CGR	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 29, 2003	K033038	GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688	NIG	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 19, 2003	K033603	INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999	LIG	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
June 20, 2003	K031606	ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY	LFX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
June 2, 2003	K031506	ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY	LGD	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
May 6, 2003	K031270	ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS	DHX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
May 2, 2003	K031297	ACCESS OV MONITOR ASSAY	LTK	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
May 2, 2003	K031269	ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS	MSW	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
January 28, 2003	K023764	UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100	JJE	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
January 17, 2003	K030012	CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372	JHX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 9, 2002	K023369	ACCESS TOTAL T4 ASSAY	KLI	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
October 16, 2001	K012900	ACCESS UNCONJUGATED ESTRIOL CALIBRATORS	JIT	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 5, 2000	K002128	ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100	NDR	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.	accessdata.fda.gov
August 22, 2000	K001935	ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565	CDZ	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
March 28, 2000	K994278	ACCESS OSTASE IMMUNOENZYMETRIC ASSAY	CIN	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
January 18, 2000	K994200	ACCESS HYBRITECH PSA QC, MODEL 37209	JJX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
January 5, 2000	K993210	ACCESS HYBRITECH FREE PSA QC, MODEL 37219	JJX	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
July 14, 1998	K982250	ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	CEC	Substantially Equivalent	Beckman Instruments, Inc.	accessdata.fda.gov
October 31, 1997	K973966	ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	CDP	Substantially Equivalent	Beckman Instruments, Inc.	accessdata.fda.gov
February 5, 1996	K955769	ACCESS PROGESTERONE ASSAY	JLS	Substantially Equivalent	Bio-Rad Laboratories, Inc.	accessdata.fda.gov
January 24, 1996	K955436	ACCESS VITAMIN B12 ASSAY (MODIFICATION)	CDD	Substantially Equivalent	Bio-Rad Laboratories, Inc.	accessdata.fda.gov
October 20, 1995	K954680	ACCESS PROLACTIN ASSAY (MODIFICATION)	CFT	Substantially Equivalent	Bio-Rad Laboratories, Inc.	accessdata.fda.gov
March 3, 1994	K940005	ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY	CGJ	Substantially Equivalent	Bio-Rad Laboratories, Inc.	accessdata.fda.gov
June 7, 1993	K930010	ACCESS THYROID UPTAKE ASSAY	CEE	Substantially Equivalent	Bio-Rad Laboratories, Inc.	accessdata.fda.gov
January 13, 1993	K925802	ACCESS DIGOXIN ASSAY	KXT	Substantially Equivalent	Bio-Rad Laboratories, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 14, 2012	P090026	ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS	OYA	28	June 16, 2025	accessdata.fda.gov
February 8, 1999	P980041	ACCESS AFP IMMUNOASSAY SYSTEM	LOK	47	November 3, 2025	accessdata.fda.gov
March 10, 1998	P970038	TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY	MTG	42	May 15, 2025	accessdata.fda.gov
February 25, 1986	P850048	TANDEM-R PSA IMMUNORADIOMETRIC ASSAY	MTF	55	September 4, 2024	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 16, 2026	98591	Class II	Ongoing	Access Total T4 Calibrator, Catalog No. 33805	Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment f	accessdata.fda.gov
November 26, 2025	98070	Class II	Ongoing	Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit	Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs o	accessdata.fda.gov
November 7, 2025	97932	Class II	Ongoing	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	It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.	accessdata.fda.gov
October 1, 2025	97730	Class II	Ongoing	Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer	An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.	accessdata.fda.gov
September 19, 2025	97638	Class II	Ongoing	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)	Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and po	accessdata.fda.gov
July 10, 2025	97255	Class II	Ongoing	Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860	Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.	accessdata.fda.gov
June 25, 2025	97162	Class II	Ongoing	UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100	Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomal	accessdata.fda.gov
May 7, 2025	96876	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer C11137	Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.	accessdata.fda.gov
May 5, 2025	96824	Class II	Ongoing	Access Testosterone assay, Catalog Number 33560	Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.	accessdata.fda.gov
April 23, 2025	96762	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20	A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.	accessdata.fda.gov
April 23, 2025	96760	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20	A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.	accessdata.fda.gov
March 27, 2025	96554	Class II	Ongoing	Beckman Coulter DxI 9000 Access Immunoassay Analyzer	When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subs	accessdata.fda.gov
February 27, 2025	97018	Class II	Completed	Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850	Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.	accessdata.fda.gov
February 6, 2025	96268	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278	Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.	accessdata.fda.gov
February 5, 2025	96256	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.	the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.	accessdata.fda.gov
February 5, 2025	96248	Class II	Ongoing	Access 2 Immunoassay Analyzer, Catalog Number 81600N	Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test result	accessdata.fda.gov
February 3, 2025	96255	Class II	Ongoing	Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal prod	Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.	accessdata.fda.gov
November 26, 2024	95871	Class II	Ongoing	Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoas	Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 1	accessdata.fda.gov
November 18, 2024	95816	Class II	Ongoing	Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.	Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can im	accessdata.fda.gov
November 13, 2024	96273	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137	The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. T	accessdata.fda.gov
September 30, 2024	95473	Class II	Ongoing	The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Syste	The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.	accessdata.fda.gov
September 5, 2024	95407	Class II	Ongoing	Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglob	IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.	accessdata.fda.gov
August 28, 2024	95296	Class II	Ongoing	The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma usi	Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.	accessdata.fda.gov
July 12, 2024	96406	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body flui	Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.	accessdata.fda.gov
July 10, 2024	95156	Class II	Ongoing	Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument	Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affect	accessdata.fda.gov
June 14, 2024	94902	Class II	Ongoing	Discrete photometric chemistry analyzer for clinical use.	Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading re	accessdata.fda.gov
June 4, 2024	94847	Class II	Ongoing	Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.	The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.	accessdata.fda.gov
May 22, 2024	94841	Class II	Ongoing	Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.	The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to t	accessdata.fda.gov
May 22, 2024	94840	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.	When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests ma	accessdata.fda.gov
April 18, 2024	95227	Class II	Ongoing	Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human	When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously hig	accessdata.fda.gov
April 18, 2024	94499	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic	Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyz	accessdata.fda.gov
March 5, 2024	94191	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.	Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.	accessdata.fda.gov
February 29, 2024	94728	Class II	Ongoing	Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determi	The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SY	accessdata.fda.gov
February 8, 2024	94012	Class II	Ongoing	Access Total T4, REF 33800, IVD, thyroxine reagent assay.	Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.	accessdata.fda.gov
February 7, 2024	94123	Class II	Ongoing	Access Substrate, REF 81906, For use with the Access Immunoassay Systems	On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cau	accessdata.fda.gov
January 3, 2024	96103	Class II	Completed	Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument	A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.	accessdata.fda.gov
November 21, 2023	93724	Class II	Ongoing	Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410	There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of IU/mL to the International System of Units (SI units	accessdata.fda.gov
September 12, 2023	93023	Class II	Ongoing	DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic	The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an err	accessdata.fda.gov
July 6, 2023	92670	Class II	Ongoing	Access Thyroglobulin Calibrators	It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.	accessdata.fda.gov
June 20, 2023	92576	Class II	Ongoing	Ringed DxI Reaction Vessels (RVs)	Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough	accessdata.fda.gov
May 17, 2023	92369	Class II	Ongoing	Access Hybritech p2PSA reagent, REF B03704 and REF A49752.	Reagent lot numbers include an insufficient concentration of blocking reagent.	accessdata.fda.gov
March 15, 2023	91916	Class II	Ongoing	Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.	The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests wil	accessdata.fda.gov
January 26, 2023	91568	Class II	Ongoing	Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531); and (4) Access 2 Section, DxC 600i	An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the	accessdata.fda.gov

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Updated April 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.