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BIO-RAD LABORATORIES INC

VARIANT II · Cardiovascular

510(k): 10 Recall: 10 UDI: 35 MAUDE: 4 Class.: 63

510(k) Clearances (10)

VARIANT II TURBO HbA1c Kit - 2.0

2015-03-24

Substantially Equivalent

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM

2014-06-25

Substantially Equivalent

VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

2013-04-25

Substantially Equivalent

VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

2012-10-26

Substantially Equivalent

VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730

2009-07-27

Substantially Equivalent

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,

2007-06-25

Substantially Equivalent

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

2007-05-07

Substantially Equivalent

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM

2006-12-27

Substantially Equivalent

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

2006-12-01

Substantially Equivalent

VARIANT II HEMOGLOBIN A1C

2004-04-15

Substantially Equivalent

Recalls (10)

VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set CD ROM - 1 Calibrator/Diluent Set Whol

2011-10-25

It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation

2011-09-12

A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation

2011-09-12

VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

2011-09-12

VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

2011-09-12

VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

2011-09-12

VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the determination of Hemoglobin A1c in human whole blood. Contents: 1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buffer 2. Elution Buffer B, 1 x 2100 mL Bis-Tris Phosphate Buffer 3. Wash/Diluent Solution, 1 x 250

2011-09-12

Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

2009-10-12

Product update kit CD rom will not upload. As a result, the device cannot be run.

Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA

2009-06-15

Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.

Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This de

2008-10-17

Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.

UDI Registrations (35)

VARIANT II TURBO

VARIANT II TURBO Hemoglobin A1c Program Calibrator/Diluent Set

VARIANT II Hemoglobin A1c

VARIANT II Hemoglobin A1c Program Prefilter

VARIANT II B-thalassemia

VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set

VARIANT II TURBO Link

VARIANT II TURBO Link Hemoglobin A1c Program Guard Cartridge

VARIANT II TURBO

VARIANT II TURBO HbA1c Kit - 2.0

VARIANT II TURBO

VARIANT II TURBO HbA1c Kit - 2.0 Calibrator/Diluent Set

VARIANT II B-thalassemia

VARIANT II B-thalassemia Short Program Elution Buffer 2

VARIANT II TURBO Link

VARIANT II TURBO Link Hemoglobin A1c Program Calibrator/Diluent Set

VARIANT II TURBO

VARIANT II TURBO Hemoglobin A1c Program Calibrator/Diluent Set

VARIANT II TURBO

VARIANT II TURBO HbA1c Kit - 2.0 Prefilter

VARIANT II TURBO

VARIANT II TURBO HbA1c Kit - 2.0 Elution Buffer A

VARIANT II B-thalassemia

VARIANT II B-thalassemia Short Program Elution Buffer 1

VARIANT II Hemoglobin A1c

VARIANT II Hemoglobin A1c Program Wash/Diluent Solution

VARIANT II

VARIANT II TURBO

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack

VARIANT II B-thalassemia

VARIANT II B-thalassemia Short Program Reorder Pack

VARIANT II TURBO

VARIANT II TURBO Hemoglobin A1c Wash/Diluent Set

VARIANT II Hemoglobin A1c

VARIANT II Hemoglobin A1c Program Elution Buffer B

VARIANT II Hemoglobin A1c

VARIANT II Hemoglobin A1c Program Analytical Cartridge

VARIANT II TURBO Link

VARIANT II TURBO Link Hemoglobin A1c Program Elution Buffer A

VARIANT II TURBO

VARIANT II TURBO Hemoglobin A1c Program Reorder Pack

VARIANT II TURBO

VARIANT II TURBO Hemoglobin A1c Program Elution Buffer A

VARIANT II TURBO

VARIANT II TURBO HbA1c Kit - 2.0 Elution Buffer B

VARIANT II TURBO

VARIANT II TURBO Hemoglobin A1c Program Analytical Cartridge

VARIANT II Hemoglobin A1c

VARIANT II Hemoglobin A1c Program Calibrator/Diluent Set

VARIANT II TURBO Link

VARIANT II TURBO Link Hemoglobin A1c Program Cartridge Set

VARIANT II / VARIANT II TURBO

VARIANT II / VARIANT II TURBO Sample Vials

VARIANT II Hemoglobin A1c

VARIANT II Hemoglobin A1c Program Reorder Pack

VARIANT II B-thalassemia

VARIANT II B-thalassemia Short Program Wash/Diluent Solution

VARIANT II TURBO

VARIANT II TURBO HbA1c Kit - 2.0 Analytical Cartridge

VARIANT II TURBO Link

VARIANT II TURBO Link Hemoglobin A1c Elution Buffer A Set

VARIANT II TURBO Link

VARIANT II TURBO Link Hemoglobin A1c Program Analytical Cartridge

VARIANT II TURBO

VARIANT II TURBO Hemoglobin Testing System WITHOUT Computer

VARIANT II TURBO

VARIANT II TURBO HbA1c Kit - 2.0

VARIANT II B-thalassemia

VARIANT II B-thalassemia Short Program Analytical Cartridge

MAUDE Adverse Events (4)

Malfunction

20141027

Malfunction

20090529

Malfunction

20090119

Other

20070820

FDA Classification (63)

Cpr Aid Feedback Device (No Software)

Cardiovascular

Dilator, Vessel, For Percutaneous Catheterization

Cardiovascular

Predictive Indicator For Long-Term Cardiovascular Outcomes

Cardiovascular

Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

Cardiovascular

Pulse Oximeter For Over-The-Counter Use

Cardiovascular

Introducer, Catheter

Cardiovascular

Catheter, Oximeter, Fiber Optic, Reprocessed

Cardiovascular

Transducer, Blood-Pressure, Extravascular

Cardiovascular

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Cardiovascular

Low Patient Acuity Monitoring System

Cardiovascular

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Cardiovascular

Outpatient Cardiac Telemetry

Cardiovascular

Apical Closure Device

Cardiovascular

Filter, Intravascular, Cardiovascular

Cardiovascular

Cardiovascular Surgical Instruments Tray

Cardiovascular

Digital Angiography Tray

Cardiovascular

Pulse-Generator, Pacemaker, External

Cardiovascular

Ultrasonic Body Composition Analyzer

Cardiovascular

Coronary Mechanical Thrombectomy With Aspiration

Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cardiovascular

Bag, Polymeric Mesh, Pacemaker

Cardiovascular

Transducer, Heart Sound

Cardiovascular

Central Venous Catheter Tray

Cardiovascular

Septostomy Catheter, Reprocessed

Cardiovascular

Oximeter, Tissue Saturation

Cardiovascular

Catheter, Intravascular, Diagnostic

Cardiovascular

Ballistocardiograph

Cardiovascular

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Cardiovascular

Monitor, St Segment

Cardiovascular

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cardiovascular

Software Device System For Estimation Of Cardiac Pressures

Cardiovascular

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Cardiovascular

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Cardiovascular

Dc-Defibrillator, Low-Energy, (Including Paddles)

Cardiovascular

Peripheral Mechanical Thrombectomy With Aspiration

Cardiovascular

Vectorcardiograph

Cardiovascular

Reprocessed Blood Pressure Cuff

Cardiovascular

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Cardiovascular

Optical Coherence Tomography, Intravascular Catheter

Cardiovascular

Holder, Heart-Valve, Prosthesis

Cardiovascular

Magnet, Test, Pacemaker

Cardiovascular

Marker, Cardiopulmonary Bypass (Vein Marker)

Cardiovascular

Catheter, Thrombus Retriever

Cardiovascular

Percutaneous Catheter, Ultrasound

Cardiovascular

Syringe, Balloon Inflation

Cardiovascular

Catheter, Intravascular Occluding, Temporary

Cardiovascular

Cannula, Catheter

Cardiovascular

Detector And Alarm, Arrhythmia

Cardiovascular

Loss Of Pulse Notification Software

Cardiovascular

Winged Intravenous Catheterization Kit

Cardiovascular

Device, Vascular, For Promoting Embolization

Cardiovascular

Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Cardiovascular

Over-The-Counter Automated External Defibrillator

Cardiovascular

Suction Control, Intracardiac, Cardiopulmonary Bypass

Cardiovascular

Injector, Contrast Medium, Automatic, Reprocessed

Cardiovascular

Clip, Vascular

Cardiovascular

Oximeter, Infrared, Sporting, Aviation

Cardiovascular

Oximeter, Ear

Cardiovascular

Electrocardiograph Software For Over-The-Counter Use

Cardiovascular

Filter, Prebypass, Cardiopulmonary Bypass

Cardiovascular

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Cardiovascular

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Cardiovascular

Computer, Diagnostic, Programmable

Cardiovascular