BECKMAN COULTER INC

AU680 · Chemistry

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

Recalls (5)

Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control

2017-02-13

Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.

AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

2015-07-30

Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.

ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.

2013-09-09

The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.

Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT)

2011-03-01

The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent OSR61177. When HbA1c APT reagent lots 9390 and 9472 are calibrated with HbA1c calibrator ODR3032, elevated recovery may be observed for patient samples. Falsely elevated HbA1c values may be interpreted as increased risk for diabetes or poorly controlled diabetes. Consequent medical acti

AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640 Clinical Chemistry Analyzer, AU640(e) Clinical Chemistry Analyzer, AU680 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laborat

2010-07-12

The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

MAUDE Adverse Events (10)

Injury

20240828

Malfunction

20240808

Malfunction

20240728

Malfunction

20240723

Malfunction

20240626

Malfunction

20240620

Malfunction

20240524

Malfunction

20240430

Malfunction

20230813

Malfunction

20220907

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