Model note · Blood Gas Analyser

Radiometer ABL800 FLEX blood gas analyser

Name: Radiometer ABL800 FLEX blood gas analyser
Brand: ABL800 FLEX

The ABL800 FLEX is a bench top blood gas analyser used in intensive care, theatres, emergency departments and central labs to measure blood gases, electrolytes, metabolites and co-oximetry on one whole blood sample. It combines electrochemical sensors with a 128 wavelength spectrophotometer, runs automated quality control through its AutoCheck module, and with the FLEXQ module can scan, mix and analyse up to three barcoded syringes without staff standing over it.

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The model

Maker, model and type.

Maker: Radiometer Medical ApS, Brønshøj, Denmark
Model: ABL800 FLEX blood gas analyser (models 393-800 and 393-801), optional FLEXQ autosampler
Device type: Blood Gas Analyser
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Parameters	Up to 18: pH, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF	Source
Minimum sample	35 uL in FLEXMODE and MICROMODE	Source
Measuring technology	Electrochemical sensors for blood gases, pH, electrolytes, glucose and lactate; 128 wavelength spectrophotometer for co-oximetry and bilirubin	Source
FLEXMODE	Automatically measures fewer parameters when the sample is too small for the full panel	Source
Quality control	AutoCheck module for automated analysis of QC fluids	Source
FLEXQ module	Holds up to three safePICO samplers, reads their barcodes and mixes each by rotating magnet for about 5 seconds before measuring	Source
Other sample type	Expired air for pO2 and pCO2	Source
FDA clearance	510(k) K041874, decision 8 October 2004, 21 CFR 862.1120, class II; FLEXQ added under K043218	Source

Recalls

Known FDA recalls.

Z-0038-20082007-06-22
Pump waste tubes made incorrectly could break at the connectors.
FDA record
Z-2571-20112011-04-07
Calcium membrane units could wrinkle and cause positive calcium bias.
FDA record
Z-1293-20152014-10-29
Negative QC drift during in use life of Crea A and B membranes.
FDA record
Z-0231-20182017-10-24
FLEXQ barcode scanner misreading a registration receipt could attach another patient's result.
FDA record
Z-0801-20192018-07-02
Creatinine could be underestimated by up to 28 percent.
FDA record
Z-1836-20202020-03-06
Incorrect power supply component could short circuit.
FDA record
Z-1684-20202020-03-10
Barcode reader misreading barcodes without a check digit.
FDA record
Z-2493-20202020-05-26
Potential patient mix up due to software issues.
FDA record
Z-1321-20222022-05-18
Sporadic biases for cNa+, cCa2+ and cK+.
FDA record
Z-2426-20242024-05-31
Falling calibration solution pH from bacterial growth could bias patient pH.
FDA record

Safety

Safety warnings from the record.

Biased pH from degraded calibration solution can lead to wrong treatment decisions if not caught by QC. Source
Creatinine could read up to 28 percent low against a reference method in some situations, a concern before contrast imaging. Source
Several software and barcode recalls involved results being linked to the wrong patient; check patient identity on every report. Source
Sporadic positive and negative biases were reported for sodium, calcium and potassium in some micro measuring modes on affected software. Source

Sources

Where this note comes from.

Not covered: The ABL800 FLEX Operator's Manual (with its troubleshooting messages chapter) is not published openly by Radiometer, so no message codes, measuring times or reagent life figures are included; reseller figures for sample volume and cycle time were left out.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

Blood Gas Analyser