BD

FACSCALIBUR · Chemistry

510(k): 0 Recall: 3 UDI: 0 MAUDE: 10 Class.: 67

Recalls (3)

BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays

2019-07-08

The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.

BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of

2015-06-15

Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).

BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

2015-03-06

The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.

MAUDE Adverse Events (10)

Malfunction

20201012

Malfunction

20200918

Malfunction

20200915

Malfunction

20200910

Malfunction

20200831

Malfunction

20200721

Malfunction

20200603

Malfunction

20200529

Malfunction

20200508

Malfunction

20200423

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