Haematology Analyser Calibration: When, How and Who Does It

Controls tell you whether today’s results can be trusted; calibration is what makes them right in the first place. How the two differ, what a calibration involves, and when an analyser really needs one.

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Also called Hematology calibration, Calibrator, Calibration verification, Haematology controls

Last updated: 13 October 2026

Calibrators, controls and verification do different jobs

All three use material with known values, which is why they are easily confused. The difference is what each is allowed to change. A calibrator adjusts the analyser; a control only checks it; verification proves the whole method works in your hands before patients are tested.

	Calibrator	Control	Method verification
Purpose	Sets the analyser’s calibration factors so results agree with reference values	Checks that results stay within limits, run after run	Proves the analyser meets its claims in your lab before go-live
Error it deals with	Systematic error — a constant bias in one direction	Detects random and systematic error but corrects neither	Measures precision, bias, carryover and range at one point in time
Values	Lot-specific assigned values, traceable to reference methods	Lot-specific targets and acceptable ranges for your analyser	Acceptance criteria written into your plan
How often	At installation and when a trigger below applies	Every day before patients, and after maintenance or lot changes	Once at installation, then after major changes
Changes the analyser?	Yes	Never	No

What a calibration involves

Which parameters

Usually only the directly measured ones — typically WBC, RBC, HGB, PLT and MCV or HCT, depending on how the analyser measures red cells. MCH and MCHC are calculated from them and follow automatically. The white-cell differential is normally not calibrated by the user; the instructions for use (IFU) list what can be adjusted on your model.

The calibrator

Most clinics and laboratories use the maker’s calibrator, whose assigned values are set for that analyser and that lot. Some reference laboratories calibrate with fresh whole blood whose values are assigned by reference methods, such as the ICSH methods for haemoglobin and packed cell volume — demanding work that is rarely practical in a clinic.

The run

The analyser measures the calibrator several times, compares the mean with the assigned values and works out new calibration factors. Most software accepts them only if the replicates agree closely and the change stays within set limits.

Afterwards

Run every level of control before any patient sample. Record the old and new factors, the calibrator lot and who did the work, and sign off the result.

Check these before you calibrate

Calibrating an analyser that is dirty, contaminated or imprecise bakes the fault into every result that follows. Rule out the simple causes first.

Daily and periodic maintenance is up to date, and the background (blank) count passes.
Reagents are within their printed and opened expiry, and the lines are primed without bubbles.
Precision is acceptable — repeated runs of one sample agree within the maker’s limits.
Carryover is within the maker’s claim, so a high sample does not contaminate the next.
The calibrator is in date, stored as labelled (usually 2–8 °C), brought to room temperature and mixed gently but thoroughly — never shaken.
The assigned values entered or scanned into the analyser match the calibrator lot in your hand.

When to recalibrate — and when not to

Situation	Recalibrate?	Notes
New analyser at installation	Yes, or confirm the factory calibration	Usually done by the supplier’s engineer or application specialist
The maker’s routine interval	Yes	Commonly every six months; follow the IFU for your model
After a major repair or part replacement	Usually	For example the haemoglobin measuring cell, the counting aperture, a pump or the main board
After the analyser is moved	Check, and recalibrate if the maker requires it	Run controls before patients either way
Persistent shift across several control levels	Only after troubleshooting	Try fresh reagent, fresh controls and cleaning first; recalibrate if the shift remains
One control out on one day	No	Rerun and investigate — recalibrating on a single failure adds error rather than removing it
A new control lot reads differently	No	Set targets for the new lot instead; the analyser has not changed

Who calibrates, and what to ask the supplier

On many compact clinic analysers, calibration is done by the supplier’s engineer at installation and at preventive-maintenance visits, while clinic staff run the daily controls. Larger laboratories usually calibrate in-house under a written procedure. Either way, settle these points in writing before you buy.

Who calibrates, how often, and whether calibration is included in the service contract.
Whether calibrator material is supplied for your own use, with its shelf life and opened stability.
Which parameters the user can adjust, and which only the engineer can.
A calibration report after every visit, showing the factors before and after.
How calibration is verified between calibrations — for example by running material of known value without adjusting anything.
MDA registration for the calibrator and controls, as well as for the analyser and reagents.

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Frequently asked questions

What is the difference between a calibrator and a control?

A calibrator is used to adjust the analyser so its results agree with reference values. A control only checks that results stay within acceptable limits, and must never be used to adjust the analyser.

How often should a haematology analyser be calibrated?

At installation, at the maker’s interval — commonly every six months — and after major repairs, part replacements or a persistent QC shift that troubleshooting does not fix. Follow the IFU for your model.

Should I recalibrate when a control fails?

Not straight away. Rerun the control, then check reagents, control material and maintenance. Recalibrate only if a shift persists across control levels once those causes are ruled out.

Can a clinic calibrate its own FBC machine?

Some analysers let trained users calibrate with the maker’s calibrator; on others the supplier’s engineer does it. Ask before you buy, and keep a calibration report either way.

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