Data / Medical devices / United States / Siemens Healthcare Diagnostics Inc.

Siemens Healthcare Diagnostics Inc.: FDA-registered device maker in E Walpole, MA, United States, 89 510(k) clearances and 15 PMA approvals

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

Siemens Healthcare Diagnostics Inc. is registered with the FDA (registration 1219913) in E Walpole, MA, United States. It lists 96 device types. The FDA files 89 510(k) clearances and 15 PMA approvals under its listings, the newest dated August 10, 2026. 74 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Siemens Healthcare Diagnostics Inc.

FDA registration number: 1219913
Address: 333 Coney Street, E Walpole, MA, United States, 02032
Owner or operator: SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
Roles: Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: April 18, 1995
Registered through: 2027
Brand names listed: 600 Series Blood Gas, ADVIA, ADVIA CENTAUR TOXOPLASM, ADVIA Centaur, ADVIA Centaur AFP, ADVIA Centaur AMH Master Curve Material (AMH MCM), ADVIA Centaur AMH Quality Control (AMH QC), ADVIA Centaur Acid and Base Reagents and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Acid, Folic, Radioimmunoassay	CGN	2	Manufacturer	accessdata.fda.gov
Acid, Lactic, Enzymatic Method	KHP	1	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	JJC	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Anti-Müllerian Hormone Test System	PQO	2	Manufacturer	accessdata.fda.gov
Antibody Igm,If, Cytomegalovirus Virus	LKQ	2	Manufacturer	accessdata.fda.gov
Antigen(Complexed),Prostate Specific,(Cpsa)	NAF	3	Manufacturer	accessdata.fda.gov
Antigen, Inflammatory Response Marker, Sepsis	NTM	2	Manufacturer for export	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Manufacturer	accessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology Assays	QCH	2	Manufacturer	accessdata.fda.gov
Bromcresol Purple Dye-Binding, Albumin	CJW	2	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	Manufacturer	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Manufacturer	accessdata.fda.gov
Chemiluminescent Immunoassay System	PKM	N	Manufacturer for export	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Manufacturer	accessdata.fda.gov
Counter (Beta, Gamma) For Clinical Use	JJJ	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Cuvette, Thermostated	JRI	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Cyclosporine	MKW	2	Manufacturer	accessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	PMT	2	Manufacturer	accessdata.fda.gov
Device, General Purpose, Hematology	LOQ	2	Manufacturer	accessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	2	Manufacturer	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer	accessdata.fda.gov
Endoscope, Neurological	GWG	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digitoxin	LFM	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Digoxin	KXT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phenobarbital	DLZ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Manufacturer	accessdata.fda.gov
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	LGR	2	Manufacturer	accessdata.fda.gov
Fluorescence Polarization Immunoassay, Theophylline	LGS	2	Manufacturer	accessdata.fda.gov
Fluorescent Immunoassay, Tobramycin	LCR	2	Manufacturer	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Manufacturer	accessdata.fda.gov
Fluorometric, Cortisol	JFT	2	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)	LOL	2	Manufacturer	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Manufacturer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Manufacturer	accessdata.fda.gov
Immunochemical, Thyroglobulin Autoantibody	JNL	2	Manufacturer	accessdata.fda.gov
Instrument, Hematocrit, Automated	GKF	2	Manufacturer	accessdata.fda.gov
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	LOK	3	Manufacturer	accessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	2	Manufacturer	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Manufacturer	accessdata.fda.gov
Prognostic Test For Assessment Of Liver Related Disease Progression	QQB	2	Manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Manufacturer	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Manufacturer	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Androstenedione	CIZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	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, Luteinizing Hormone	CEP	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	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, Total Thyroxine	CDX	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	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	Manufacturer	accessdata.fda.gov
System, Test, Her-2/Neu, Monitoring	NCW	2	Manufacturer	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	Manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Manufacturer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Manufacturer	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Manufacturer	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Manufacturer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	MTG	3	Manufacturer	accessdata.fda.gov
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	MTF	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer	accessdata.fda.gov
Zika Virus Serological Reagents	QFO	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
August 10, 2026	K253528	Atellica IM CA 19-9 II	NIG	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
January 5, 2026	K251630	Atellica IM Total PSA II (tPSAII)	LTJ	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
December 4, 2025	K250816	ADVIA Centaur Anti-Thyroglobulin II (aTgII)	JNL	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 17, 2025	K250250	ADVIA Centaur Anti-Thyroid Peroxidase II	JZO	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
June 20, 2025	K242981	Atellica IM Thyroglobulin (Tg)	MSW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 25, 2024	K241165	Atellica® IM High-Sensitivity Troponin I (TnIH)	MMI	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
April 4, 2024	K233050	ADVIA Centaur® TSH3-Ultra II (TSH3ULII)	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
September 24, 2023	K220265	ADVIA Centaur® NT-proBNPII (PBNPII)	NBC	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 13, 2023	K222116	Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
June 2, 2023	K221801	ADVIA Centaur® Anti-Müllerian Hormone (AMH)	PQO	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
August 20, 2021	DEN190056	ADVIA Centaur Enhanced Liver Fibrosis (ELF)	QQB	Unknown	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 13, 2021	K200210	ADVIA Centaur® Total hCG assay	DHA	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
April 13, 2020	K200215	ADVIA Centaur CEA Assay	DHX	Substantially Equivalent	Siemens Healthcare Disgnostics, Inc.	accessdata.fda.gov
April 6, 2020	K200199	ADVIA Centaur CA 125II	LTK	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
November 22, 2019	K192777	ADVIA Centaur CA 15-3 assay	MOI	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 30, 2019	K192790	Atellica IM Total hCG (ThCG)	DHA	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
August 28, 2019	K191533	ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG	CDZ	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 17, 2019	K191578	ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control	QFO	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 30, 2018	K181213	ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control	LFZ	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 16, 2018	K181002	Atellica IM BRAHMS Procalcitonin (PCT)	PMT	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 12, 2018	K171274	ADVIA Centaur High-Sensitivity Troponin I (TNIH)	MMI	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
April 12, 2018	K172201	Atellica IM Folate Assay	CGN	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
August 31, 2017	K171642	Atellica IM Ferritin Assay	DBF	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
May 23, 2017	K163658	ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay	CEW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
June 29, 2016	K151986	ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material	CDZ	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
May 1, 2015	K150403	ADVIA Centaur TSH3-Ultra	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
January 27, 2015	K143680	ADVIA Centaur IgE Master Curve Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
December 23, 2014	K143376	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
December 5, 2014	K143194	ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
July 24, 2014	K133156	ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA	MRG	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
March 31, 2014	K140505	ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
March 10, 2014	K140267	ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
February 5, 2014	K133601	ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY	CEW	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
September 13, 2013	K132249	ADVIA CENTAUR FT4, ADVIA CENTAUR T4	CEC	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
March 21, 2013	K121981	ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY	CEW	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
January 20, 2012	K112343	TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS	LIP	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
October 14, 2011	K110586	ADVIA CENTAUR VITAMIN D TOTAL ASSAY	MRG	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
June 2, 2011	K103548	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	JIT	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.	accessdata.fda.gov
November 23, 2010	K102904	ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
May 13, 2010	K100433	IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,	LKQ	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
March 19, 2010	K100293	ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810	JIT	Substantially Equivalent	Siemens Heatlhcare Diagnostics, Inc.	accessdata.fda.gov
November 20, 2009	K092993	ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
August 14, 2009	K091123	ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS	JJX	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
May 8, 2009	K083844	ADVIA CENTAUR TSH3-ULTRA METHOD	JLW	Substantially Equivalent	Siemens Healthcare Diagnostics	accessdata.fda.gov
September 11, 2008	K071455	ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR	MKW	Substantially Equivalent	Siemens Medical Solutions Diagnostics	accessdata.fda.gov
July 2, 2004	K041133	MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER	CDD	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
June 14, 2004	K040425	ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS	NBC	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
December 17, 2003	K031560	BAYER RAPIDLAB 1200 SYSTEM	CHL	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
September 9, 2003	K032525	BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER	NBC	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
June 24, 2003	K031393	BAYER ADVIA CENTAUR CA 19-9 ASSAY	NIG	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
June 23, 2003	K031038	ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY	NBC	Substantially Equivalent	Bayer Healthcare, LLC	accessdata.fda.gov
January 30, 2003	K024017	BAYER ADVIA CENTAUR HER-2/NEU ASSAY	NCW	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
July 24, 2002	K020828	CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM	LTK	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
March 27, 2002	K020806	ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY	LOJ	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
March 15, 2002	K020217	ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY	JJX	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
February 28, 2002	K012357	CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM	MOI	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
December 27, 2001	K012183	BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY	LGD	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
December 18, 2001	K013406	ADVIA CENTAUR HOMOCYSTEINE ASSAY	LPS	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
October 22, 2001	K012777	ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS	JZO	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
August 20, 2001	K010755	BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY	LGD	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
July 5, 2001	K010668	BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY	LFX	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
July 2, 2001	K011303	RANDOX PHENOBARBITAL	DLZ	Substantially Equivalent	Randox Laboratories, Ltd.	accessdata.fda.gov
April 13, 2001	K003412	ADVIA CENTAUR RUBELLA IGG ASSAY	LFX	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
February 5, 2001	K010050	ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY	CGN	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
December 19, 2000	K002738	BAYER RAPIDPOINT 400 SYSTEM	CHL	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
December 5, 2000	K003291	BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY	JZO	Substantially Equivalent	Bayer Diagnostics Corp.	accessdata.fda.gov
December 16, 1999	K993571	BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12	CDD	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
December 6, 1999	K993309	BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY	MMI	Substantially Equivalent	Bayer Corp.	accessdata.fda.gov
November 12, 1999	K993254	IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06	CGN	Substantially Equivalent	Diagnostic Products Corp.	accessdata.fda.gov
August 5, 1999	K992157	CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY	DBF	Substantially Equivalent	Chiron Diagnostics Corp.	accessdata.fda.gov
June 18, 1999	K991692	CHIRON DIAGNOSTICS ACS: 180 FT3	CDP	Substantially Equivalent	Chiron Diagnostics Corp.	accessdata.fda.gov
October 15, 1998	K982680	CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY	MOI	Substantially Equivalent	Chiron Diagnostics Corp.	accessdata.fda.gov
August 12, 1998	K981478	ACS:CENTAUR CEA	DHX	Substantially Equivalent	Chiron Diagnostics Corp.	accessdata.fda.gov
December 8, 1997	K974325	CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN	DDR	Substantially Equivalent	Chiron Diagnostics Corp.	accessdata.fda.gov
March 24, 1997	K970539	CHIRON DIAGNOSTICS ACS:180TU P	KHQ	Substantially Equivalent	Chiron Diagnostics Corp.	accessdata.fda.gov
November 5, 1996	K962559	ACS CORTISOL IMMUNOASSAY	JFT	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
June 21, 1996	K962126	ACS CKMB II IMMUNOASSAY	JHS	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
June 21, 1996	K962041	ACS LH2 IMMUNOASSAY	CEP	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
June 17, 1996	K961510	ACS FRT4 IMMUNOASSAY	JJX	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
March 11, 1996	K955873	ACS PHENYTOIN ASSAY	LGR	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
August 2, 1993	K932955	CIBA CORNING ACS PROGESTERONE IMMUNOASSAY	JLS	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
March 19, 1993	K925277	CIBA CORNING ACS HCG IMMUNOASSAY	JHI	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
April 8, 1992	K920372	ACS TOTAL IGE IMMUNOASSAY	DGC	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
October 25, 1991	K913646	CIBA CORNING ACS T3 IMMUNOASSAY	CDD	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
April 3, 1991	K911121	CIBA CORNING ACS CKMB IMMUNOASSAY	JHX	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
February 4, 1991	K910198	CIBA CORNING ACS LH IMMUNOASSAY	CEP	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
January 15, 1991	K905532	CIBA CORNING ACS T4 IMMUNOASSAY	CDX	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
November 20, 1990	K904649	CIBA CORNING ACS FSH IMMUNOASSAY	CGJ	Substantially Equivalent	Ciba Corning Diagnostics Corp.	accessdata.fda.gov
November 7, 1990	K904714	CIBA CORNING ACS PROLACTIN IMMUNOASSAY	CFT	Substantially Equivalent	Ciba Corning Diagnostics Corp.	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
May 11, 2026	P250026	Atellica IM free PSA II (fPSAII)	MTG	0	May 11, 2026	accessdata.fda.gov
December 3, 2025	P240021	Atellica IM Total PSA II (tPSAII)	MTF	1	August 26, 2026	accessdata.fda.gov
July 27, 2022	P210019	ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)	SEI	4	October 17, 2025	accessdata.fda.gov
May 16, 2014	P110041	ADVIA CENTAUR HBSAGII	LOM	17	October 17, 2025	accessdata.fda.gov
January 20, 2012	P100039	ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL	SEI	17	October 17, 2025	accessdata.fda.gov
October 11, 2011	P090024	ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL	LOM	13	October 17, 2025	accessdata.fda.gov
May 26, 2005	P030049	ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL	LOM	14	March 11, 2021	accessdata.fda.gov
March 7, 2005	P040017	ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS	LOL	0	March 7, 2005	accessdata.fda.gov
December 22, 2004	P040018	ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS	LOL	0	December 22, 2004	accessdata.fda.gov
December 22, 2004	P040004	ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS	SEI	20	March 29, 2022	accessdata.fda.gov
December 22, 2004	P030056	ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS	MZO	18	April 27, 2021	accessdata.fda.gov
August 6, 2004	P030040	ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS	SEI	23	October 17, 2025	accessdata.fda.gov
September 8, 2000	P990055	BAYER IMMUNO 1 COMPLEXED PSA ASSAY	NAF	28	July 16, 2025	accessdata.fda.gov
December 22, 1995	P950021	ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY	MTG	29	July 16, 2025	accessdata.fda.gov
September 29, 1995	P930036	ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS	LOK	25	May 11, 2026	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
July 13, 2026	99446	Class II	Ongoing	Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL	Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.	accessdata.fda.gov
June 26, 2026	99381	Class III	Ongoing	Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL	out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome be	accessdata.fda.gov
October 6, 2025	97819	Class II	Ongoing	IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6	The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.	accessdata.fda.gov
September 22, 2025	97672	Class II	Ongoing	Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6	The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.	accessdata.fda.gov
April 15, 2025	96693	Class II	Ongoing	Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498	Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.	accessdata.fda.gov
November 22, 2024	95809	Class II	Ongoing	epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of	Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction	accessdata.fda.gov
September 30, 2024	95513	Class II	Ongoing	IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)	The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).	accessdata.fda.gov
July 26, 2024	95118	Class II	Ongoing	Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490	Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.	accessdata.fda.gov
April 23, 2024	94495	Class II	Ongoing	IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.	The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.	accessdata.fda.gov
January 9, 2023	91522	Class II	Ongoing	Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.	accessdata.fda.gov
December 22, 2022	91552	Class II	Ongoing	ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old	Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample	accessdata.fda.gov
November 4, 2022	91164	Class II	Ongoing	IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement o	Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result	accessdata.fda.gov
October 25, 2022	91108	Class II	Ongoing	IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.	Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 we	accessdata.fda.gov
August 11, 2022	90812	Class II	Ongoing	IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)	An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid	accessdata.fda.gov
March 3, 2022	89953	Class II	Ongoing	Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots	Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results	accessdata.fda.gov
September 28, 2021	88792	Class II	Ongoing	Atellica IM 1300 Analyzer, SMN 11066001	Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.	accessdata.fda.gov
September 22, 2021	88768	Class II	Terminated	Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861	Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.	accessdata.fda.gov
July 6, 2021	88431	Class II	Ongoing	Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478	Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers	accessdata.fda.gov
April 21, 2021	87770	Class II	Ongoing	Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System an	Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems	accessdata.fda.gov
February 8, 2021	87381	Class II	Terminated	Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2	Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.	accessdata.fda.gov
August 25, 2020	86383	Class II	Terminated	Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pac	Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.	accessdata.fda.gov
August 14, 2019	83653	Class II	Terminated	Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative dete	Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated	accessdata.fda.gov
July 22, 2019	84078	Class II	Terminated	Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308	Homocysteine Assay May Cause Elevated Results in the Folate Assay	accessdata.fda.gov
December 7, 2018	82521	Class II	Terminated	Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398	Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).	accessdata.fda.gov
July 24, 2018	80954	Class II	Terminated	ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.	A potential bias was identified with certain kits compared to the internal standards.	accessdata.fda.gov
February 21, 2018	79678	Class II	Terminated	ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)	Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.	accessdata.fda.gov
July 28, 2017	79170	Class II	Terminated	ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of	Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.	accessdata.fda.gov
June 7, 2017	78645	Class II	Terminated	ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.	Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).	accessdata.fda.gov
April 5, 2017	76992	Class II	Terminated	ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899	Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previou	accessdata.fda.gov
March 8, 2017	76766	Class II	Terminated	Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen	Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems	accessdata.fda.gov
January 10, 2017	76285	Class II	Terminated	Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)	Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A k	accessdata.fda.gov
January 4, 2017	76212	Class II	Terminated	ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimen	DHEA-S causes falsely elevated progesterone results.	accessdata.fda.gov
October 19, 2016	75523	Class II	Terminated	ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 as	CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.	accessdata.fda.gov
October 5, 2016	75394	Class II	Terminated	Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test)	Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples	accessdata.fda.gov
August 9, 2016	74917	Class II	Terminated	ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)	Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.	accessdata.fda.gov
August 8, 2016	74951	Class II	Terminated	Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)	Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization	accessdata.fda.gov
May 2, 2016	74036	Class II	Terminated	Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay. In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum	Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin	accessdata.fda.gov
February 4, 2016	73263	Class II	Terminated	Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur sys	ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay	accessdata.fda.gov
January 13, 2016	73052	Class II	Terminated	Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (hepa	The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.	accessdata.fda.gov
December 29, 2015	72968	Class II	Terminated	ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure p	PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).	accessdata.fda.gov
July 27, 2015	71843	Class II	Terminated	ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.	Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.	accessdata.fda.gov
May 19, 2015	71337	Class II	Terminated	ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma,	System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.	accessdata.fda.gov
May 6, 2015	71073	Class II	Terminated	The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.	D50 and D51 Diagnostic error codes are not functional.	accessdata.fda.gov
January 27, 2015	70470	Class II	Terminated	ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.	ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)	accessdata.fda.gov
October 6, 2014	69461	Class III	Terminated	ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No.	Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.	accessdata.fda.gov
September 26, 2014	69430	Class II	Terminated	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)	Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.	accessdata.fda.gov
September 19, 2014	69228	Class II	Terminated	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.	The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.	accessdata.fda.gov
September 15, 2014	69292	Class II	Terminated	Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qua	Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.	accessdata.fda.gov
September 12, 2014	69282	Class III	Terminated	ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution	Stability of the ADVIA Centaur Cleaning Solution is not assured	accessdata.fda.gov
June 23, 2014	68665	Class II	Terminated	SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP Sy	Complaints of failed calibration.	accessdata.fda.gov
June 2, 2014	68537	Class II	Terminated	Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a co	Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles	accessdata.fda.gov
May 30, 2014	68520	Class II	Terminated	ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790	The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.	accessdata.fda.gov
April 10, 2014	67953	Class II	Terminated	ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Cent	Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.	accessdata.fda.gov
March 25, 2014	67839	Class II	Terminated	Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vit	Serum controls may go out of range low with the ADVIA Centaur Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223	accessdata.fda.gov
December 18, 2013	67021	Class II	Terminated	ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems	ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.	accessdata.fda.gov
August 16, 2013	66132	Class III	Terminated	ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.	PTH Calibrator packaged with only high calibrator.	accessdata.fda.gov
July 25, 2013	65806	Class II	Terminated	ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.	Calibration failures and/or significant negative shifts in quality control (QC) and patient results.	accessdata.fda.gov
June 28, 2013	65626	Class III	Terminated	ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THE	Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.	accessdata.fda.gov
June 25, 2013	65562	Class II	Terminated	ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP	ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).	accessdata.fda.gov
May 14, 2013	65224	Class II	Terminated	ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).	iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability	accessdata.fda.gov
May 10, 2013	65162	Class II	Terminated	ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).	A rare variant of TSH, identified in a small cluster of patients, is not detected.	accessdata.fda.gov
March 13, 2013	64610	Class II	Terminated	ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.	Negative bias in patient samples for Vitamin D	accessdata.fda.gov
November 14, 2012	63682	Class II	Terminated	Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide	Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.	accessdata.fda.gov
October 9, 2012	69449	Class II	Terminated	ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)	Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system	accessdata.fda.gov
September 11, 2012	63167	Class II	Terminated	Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked	BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.	accessdata.fda.gov
August 7, 2012	62897	Class III	Terminated	ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product	ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40	accessdata.fda.gov
July 25, 2012	62702	Class II	Terminated	Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (1103	Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays	accessdata.fda.gov
July 17, 2012	62640	Class II	Terminated	Siemens ADVIA Centaur Syphilis (SYPH) Assay, 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antib	Syphilis Assay Interference with HBsAg Assay	accessdata.fda.gov
March 6, 2012	61393	Not yet classified	Terminated	Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the	Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims	accessdata.fda.gov
February 16, 2012	61236	Not yet classified	Terminated	Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) us	Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.	accessdata.fda.gov
November 11, 2011	60502	Not yet classified	Terminated	ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50 Test kit w/o Calibrators 10491244 - 250 Test kit w/Calibrators 10491379 - 50 Test kit w/Calibrators The ADVIA C	Positive bias of 14% and higher for some individual points for CA 19-9 results generated on the ADVIA Centaur CP system when they are compared to CA 19-9 assay results generated on either the ADVIA Centaur or ADVIA Centaur XP systems	accessdata.fda.gov
December 14, 2010	57427	Not yet classified	Terminated	ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: 09427226 (128532) 100 test kit Product code: 01678114 (128533) 500 Test kit	Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal	accessdata.fda.gov
October 3, 2008	60321	Not yet classified	Terminated	ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone	Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias	accessdata.fda.gov
January 12, 2008	46346	Not yet classified	Terminated	ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.	Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.	accessdata.fda.gov

Compare with other makers

Updated August 17, 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.