RADIOMETER AMERICA INC

ABL90 FLEX · Cardiovascular

510(k): 0 Recall: 8 UDI: 0 MAUDE: 0 Class.: 63

Recalls (8)

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

2019-07-10

Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-c

2018-05-25

The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again

ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

2017-01-26

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

2014-12-08

The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.

ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

2013-10-15

RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.

ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

2012-07-05

A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t

ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose,

2011-01-12

Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the

ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.

2010-11-01

Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.

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