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SIEMENS HEALTHCARE DIAGNOSTICS INC

EPOC · Chemistry

510(k): 0 Recall: 10 UDI: 0 MAUDE: 5 Class.: 67

Recalls (10)

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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in th
2024-11-22

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 has the potential to impact patient s…

epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in t
2024-11-22

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 has the potential to impact patient sa…

epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in t
2024-11-22

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 has the potential to impact patient s…

epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in t
2024-11-22

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 has the potential to impact patient s…

epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in t
2024-11-22

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 has the potential to impact patient s…

epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in
2024-11-22

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 has the potential to impact patient s…

epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood
2024-11-22

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 has the potential to impact patient s…

epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; 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 heparinized or un-anticoagulated arterial, venous or capillary whole blood in t
2024-11-22

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 has the potential to impact patient s…

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
2024-09-24

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testin…

epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
2023-10-19

Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/o…

MAUDE Adverse Events (5)

Malfunction
20260326
Malfunction
20241003
Malfunction
20240808
Malfunction
Malfunction

FDA Classification (67)

Mixer, Blood Tube

Clinical Chemistry

Bromcresol Green Dye-Binding, Albumin

Clinical Chemistry

Acid Phosphatase, Disodium Phenylphosphate

Clinical Chemistry

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Clinical Chemistry

Chromatography Separation/Zimmerman 17-Ketogenic Steroids

Clinical Chemistry

Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Clinical Chemistry

Conversion To Creatinine, Creatine

Clinical Chemistry

Electrode, Ion Specific, Urea Nitrogen

Clinical Chemistry

Breast Milk Macronutrients Test System

Clinical Chemistry

Acid, Ferric Ion-Sulfuric, Cholesterol

Clinical Chemistry

Fluorometric Method, Triglycerides

Clinical Chemistry

Prognostic Test For Development Or Progression Of Preeclampsia

Clinical Chemistry

Fluorometer, For Clinical Use

Clinical Chemistry

Spectrophotometric, Uroporphyrin

Clinical Chemistry

Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)

Clinical Chemistry

Fluorometric Method, 17-Hydroxycorticosteroids

Clinical Chemistry

Prescription Use Blood Glucose Meter For Near-Patient Testing

Clinical Chemistry

Droplet Digital Pcr System

Clinical Chemistry

Flame Emission Photometer For Clinical Use

Clinical Chemistry

Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes

Clinical Chemistry

Acid, Uric, Uricase (Colorimetric)

Clinical Chemistry

Acid, Lactic, Enzymatic Method

Clinical Chemistry

Indicator, Alumina Fluorescent, Tlc

Clinical Chemistry

Radioimmunoassay For Cyclosporine

Clinical Chemistry

Blood Collection Device For Cell-Free Nucleic Acid

Clinical Chemistry

Galectin-3 In Vitro Diagnostic Assay

Clinical Chemistry

Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline

Clinical Chemistry

Plate, Silica Gel, Tlc

Clinical Chemistry

Radioimmunoassay, C-Peptides Of Proinsulin

Clinical Chemistry

System, Breath Measurement

Clinical Chemistry

Radial Diffusion, Amylase

Clinical Chemistry

Radioimmunoassay, Cortisol

Clinical Chemistry

Chromatographic/Fluorometric Method, Catecholamines

Clinical Chemistry

Photometric Method, Ammonia

Clinical Chemistry

Insulin Pump Secondary Display

Clinical Chemistry

Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma

Clinical Chemistry

Apolipoproteins

Clinical Chemistry

Radioimmunoassay, Thyroxine-Binding Globulin

Clinical Chemistry

Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase

Clinical Chemistry

Turbidimetric Method, Globulin

Clinical Chemistry

2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)

Clinical Chemistry

Cuvette, Thermostated

Clinical Chemistry

Turbidimetric, Total Protein

Clinical Chemistry

Vanillin Pyruvate, Ast/Sgot

Clinical Chemistry

Internal Polymerase Chain Reaction Control, Not Assay Specific

Clinical Chemistry

Ph Rate Measurement, Carbon-Dioxide

Clinical Chemistry

Cresolphthalein Complexone, Calcium

Clinical Chemistry

Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

Clinical Chemistry

Radioimmunoassay, Pregnenolone

Clinical Chemistry

Immunoassay Method, Troponin Subunit

Clinical Chemistry

Cyclosporine

Clinical Chemistry

Setmelanotide Eligibility Gene Variant Detection System

Clinical Chemistry

Unit, Filter, Membrane

Clinical Chemistry

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Clinical Chemistry

Shaker/Stirrer

Clinical Chemistry

Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Clinical Chemistry

Instrumentation, High Pressure Liquid Chromatography

Clinical Chemistry

Radioimmunoassay, Gastrin

Clinical Chemistry

Refractometer For Donor Testing

Clinical Chemistry

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Clinical Chemistry

Radioassay, Intrinsic Factor Blocking Antibody

Clinical Chemistry

Radioimmunoassay, Acth

Clinical Chemistry

Enzymatic Method, Bilirubin

Clinical Chemistry

L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

Clinical Chemistry

Automated Radioimmunoassay Systems, For Clinical Use

Clinical Chemistry

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Clinical Chemistry

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Clinical Chemistry