Data / Medical devices / Ireland / Beckman Coulter Ireland Inc

Beckman Coulter Ireland Inc: FDA-registered device maker in O CALLAGHANS MILLS Clare, Ireland, 54 510(k) clearances

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

Beckman Coulter Ireland Inc is registered with the FDA (registration 9680746) in O CALLAGHANS MILLS Clare, Ireland. It lists 100 device types. The FDA files 54 510(k) clearances under its listings, the newest dated March 23, 2022. 4 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 Ireland Inc

FDA registration number: 9680746
FEI number: 1000206808
Address: Lismeehan, O CALLAGHANS MILLS Clare, Ireland, --
Owner or operator: BECKMAN COULTER, INC. (2050012)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: December 14, 1977
Registered through: 2026
Brand names listed: 442655 Lactate Dehydrogenase Reagent (LD 2 x 200), 442660 Lactate Dehydrogenase Reagent (LD-P 2 x 200), 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 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	Contract manufacturer	accessdata.fda.gov
Acid, Lactic, Enzymatic Method	KHP	1	Manufacturer	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Manufacturer	accessdata.fda.gov
Albumin, Antigen, Antiserum, Control	DCF	2	Manufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	LKL	1	Manufacturer	accessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Contract manufacturer	accessdata.fda.gov
Anti-Müllerian Hormone Test System	PQO	2	Contract manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Manufacturer	accessdata.fda.gov
Assayed Quality Control Material For Clinical Microbiology Assays	QCH	2	Contract manufacturer	accessdata.fda.gov
Automated Urinalysis System	KQO	1	Contract manufacturer	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Manufacturer	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Contract manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Contract manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
Bromcresol Purple Dye-Binding, Albumin	CJW	2	Contract manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Contract manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Contract manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	2	Manufacturer	accessdata.fda.gov
Ceruloplasmin, Antigen, Antiserum, Control	DDB	2	Manufacturer	accessdata.fda.gov
Colorimetric Method, Cpk Or Isoenzymes	JHY	2	Manufacturer	accessdata.fda.gov
Colorimetry, Cholinesterase	DIH	1	Manufacturer	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Manufacturer	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Manufacturer	accessdata.fda.gov
Conductivity Rate, Urea Nitrogen	LFP	2	Contract manufacturer	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Contract manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	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
Electrode, Ion Specific, Calcium	JFP	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Contract manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Phenobarbital	DLZ	2	Contract manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Manufacturer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Manufacturer	accessdata.fda.gov
Fibrin Split Products	GHH	2	Manufacturer	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Contract manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Contract manufacturer	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Manufacturer	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Manufacturer	accessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)	LOL	2	Contract manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Manufacturer	accessdata.fda.gov
Ige, Antigen, Antiserum, Control	DGC	2	Manufacturer, Specification developer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Contract manufacturer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Contract manufacturer	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Manufacturer	accessdata.fda.gov
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	2	Contract manufacturer	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Contract manufacturer	accessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Contract manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	2	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Contract manufacturer	accessdata.fda.gov
Ph Rate Measurement, Carbon-Dioxide	JFL	2	Contract manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Prealbumin, Fitc, Antigen, Antiserum, Control	DDS	1	Manufacturer	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Contract manufacturer	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Contract manufacturer	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), Ferritin	JMG	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Contract manufacturer	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Contract manufacturer	accessdata.fda.gov
Starch-Dye Bound Polymer, Amylase	CIW	2	Manufacturer	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Manufacturer	accessdata.fda.gov
System, Test, C-Reactive Protein	DCN	2	Manufacturer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Contract manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Contract manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Contract manufacturer	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Contract manufacturer	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Contract manufacturer	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Contract manufacturer	accessdata.fda.gov
Transferrin, Rhodamine, Antigen, Antiserum, Control	DDD	2	Manufacturer	accessdata.fda.gov
Turbidimetric Method, Lipoproteins	JHN	1	Manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	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 23, 2022	K220178	Total Immunoglobulin E (IgE)	DGC	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
January 16, 2019	K182651	HbA1c Advanced	PDJ	Substantially Equivalent	Beckman Coulter Ireland, Inc.	accessdata.fda.gov
January 9, 2017	K161508	Ceruloplasmin	DDB	Substantially Equivalent	Beckman Coulter Ireland, Inc.	accessdata.fda.gov
October 15, 2014	K142346	Urine/CSF Albumin, Urine/CSF Albumin Calibrator	DCF	Substantially Equivalent	Beckman Coulter Ireland, Inc.	accessdata.fda.gov
July 11, 2014	K141388	SYSTEM CALIBRATER	JIX	Substantially Equivalent	Beckman Coulter Ireland, Inc.	accessdata.fda.gov
June 30, 2014	K141374	BICARBONATE CALIBRATOR	JIT	Substantially Equivalent	Beckman Coulter Ireland, Inc.	accessdata.fda.gov
October 9, 2013	K131546	AU BICARBONATE REAGENT	KHS	Substantially Equivalent	Beckman Coulter Ireland, Inc.	accessdata.fda.gov
October 12, 2012	K120199	GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY	LCP	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
February 7, 2011	K103373	SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722	DIH	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
December 11, 2009	K092505	BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203	DBF	Substantially Equivalent	Beckman Coulter, Inc.	accessdata.fda.gov
September 5, 2008	K080435	OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181	CIG	Substantially Equivalent	Olympus Life Science Research Europa GmbH (Europa)	accessdata.fda.gov
February 11, 2008	K073490	OLYMPUS IGG REAGENT	CFN	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
February 11, 2008	K073489	OLYMPUS IGA REAGENT	CFN	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
February 11, 2008	K073487	OLYMPUS IGM REAGENT	CFN	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
June 11, 2007	K070453	OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL	GHH	Substantially Equivalent	Olympus Life & Material Science Europa GmbH (Irish	accessdata.fda.gov
June 4, 2007	K070835	OLYMPUS CK-MB REAGENT	JHY	Substantially Equivalent	Olympus Life & Material Science Europa GmbH (Irish	accessdata.fda.gov
April 6, 2007	K062862	OLYMPUS URIC ACID REAGENT, MODEL OSR6X98	KNK	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
March 23, 2007	K063804	OLYMPUS TRIGLYCERIDE TEST SYSTEM	CDT	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
October 5, 2006	K061575	OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117	CJY	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
June 6, 2006	K060201	OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.	DHR	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
August 22, 2005	K051564	OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH	NQD	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
January 31, 2005	K043460	OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071	JIX	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
December 23, 2004	K043202	OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279	CGS	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
July 16, 2004	K041793	OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524	JMO	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
April 8, 2004	K040692	OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023	JIT	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
March 10, 2004	K040471	OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024	JIT	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
January 30, 2004	K033910	OLYMPUS URINE CALIBRATOR	JIX	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
August 21, 2003	K032285	OLYMPUS PREALBUMIN CALIBRATOR, ODR3029	JIT	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
February 21, 2003	K030045	OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)	DIH	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
November 24, 1999	K993444	K-ASSAY ALPHA-1 AT	DEM	Substantially Equivalent	Kamiya Biomedical Co.	accessdata.fda.gov
August 19, 1999	K992086	OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2	JIX	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
May 11, 1999	K991136	B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM	JZG	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
May 7, 1998	K981305	OLYMPUS SERUM PROTEIN MULTICALIBRATOR	JIX	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
February 6, 1997	K963139	OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT	DDD	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
January 14, 1997	K963424	OLYMPUS LIPASE REAGENT	CDT	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
October 18, 1996	K962582	OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT	DBI	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
October 18, 1996	K962409	OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT	CZW	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
February 14, 1996	K954537	OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT	DCN	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
July 5, 1995	K952425	OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT	JHN	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
June 5, 1995	K952466	OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT	JHN	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
December 27, 1994	K944407	OLYMPUS MAGNESIUM REAGENT	JGJ	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
February 5, 1993	K925339	OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT	CKA	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
January 26, 1993	K925155	OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT	CIT	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
December 18, 1992	K924691	OLYMPUS IRON REAGENT	JIY	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
December 3, 1992	K924964	OLYMPUS TOTAL BILIRUBIN REAGENT	CIG	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
December 3, 1992	K924601	OLYMPUS GLUCOSE REAGENT	CFR	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
November 30, 1992	K924963	OLYMPUS DIRECT BILIRUBIN REAGENT	CIG	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
November 25, 1992	K924693	OLYMPUS BUN REAGENT	CDQ	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
November 19, 1992	K925057	OLYMPUS INORGANIC PHOSPHORUS REAGENT	CEO	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
November 18, 1992	K925156	OLYMPUS ALKALINE PHOSPHATASE REAGENT	CJE	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
October 19, 1992	K924692	OLYMPUS CREATININE REAGENT	CGX	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
October 19, 1992	K924339	OLYMPUS AMYLASE REAGENT	CIW	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
July 21, 1992	K921718	OLYMPUS ISE MODULE	JGS	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov
July 17, 1992	K922369	OLYMPUS ALBUMIN REAGENT	CIX	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
December 8, 2025	98094	Class II	Ongoing	The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholestero	Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) an	accessdata.fda.gov
October 14, 2025	97842	Class II	Ongoing	BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.	Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.	accessdata.fda.gov
April 23, 2025	96746	Class III	Ongoing	Apo B Reagent, REF: OSR6143	The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating	accessdata.fda.gov
September 6, 2023	93206	Class II	Ongoing	AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection	The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mod	accessdata.fda.gov

Compare with other makers

Updated January 21, 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.