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What This Guide Helps With
Use when assay calibration will not start, fails, produces unacceptable status, or repeatedly stops before completion.
Step-by-Step Troubleshooting
1. Protect Patient Results
Do not report affected patient results when required calibration is invalid or incomplete. Route testing to another validated system if necessary.
Expected outcome: No patient results are released from an assay with unresolved calibration status.
2. Identify the Affected Assay and Failure Pattern
Determine whether the problem affects one assay or multiple assays and whether calibration fails immediately, during processing, or after result evaluation. Record the displayed message or status.
Expected outcome: The failure is categorized as assay-specific or system-wide.
3. Verify Calibration Material
Confirm the correct calibrator is being used, is within acceptable dating, has been stored and prepared according to laboratory requirements, and shows no visible contamination, evaporation, or container damage.
Expected outcome: Calibration material is appropriate and suitable for use.
4. Verify Reagent Condition
Confirm the reagent associated with the affected assay is correctly identified, seated, within accepted dating, and not displaying a separate reagent problem.
Expected outcome: Required reagent is available and correctly recognized.
5. Check Sample Cups, Tubes, and Volume
Verify calibrator containers are compatible, properly positioned, sufficiently filled for the planned process, and free of bubbles, clots, foam, or obvious contamination.
Expected outcome: Calibration samples are presented correctly for aspiration and measurement.
6. Check Analyzer Readiness
Confirm there are no unresolved wash, waste, fluidics, aspiration, temperature, or other normal-interface conditions that would reasonably affect calibration.
Expected outcome: No broader analyzer condition is present that would invalidate calibration.
7. Repeat With Fresh Approved Material When Appropriate
If laboratory procedure permits, repeat calibration using fresh or known-good calibration material after correcting any external setup issue. Avoid repeated attempts using questionable material.
Expected outcome: Successful calibration with fresh material identifies the original calibrator or preparation as the likely cause. Troubleshooting can stop after required verification.
8. Confirm Calibration Acceptance and QC
Verify the analyzer accepts the completed calibration and perform required QC before patient testing resumes.
Expected outcome: Calibration is accepted and subsequent QC meets laboratory acceptance criteria. Troubleshooting can stop.
If the Problem Persists
Calibrator condition, reagent status, specimen presentation, and obvious analyzer readiness issues have been ruled out. Remaining possibilities include assay-specific performance problems, fluidics or aspiration instability, photometric or measurement subsystem issues, temperature control, calibration data handling, or other service-level conditions.
Remove affected testing from service and label the analyzer Out of Service if reliable testing cannot continue. Arrange qualified evaluation using Beckman Coulter documentation and approved test equipment. Do not make unauthorized calibration adjustments or internal configuration changes.
Return the affected assay or analyzer to service only after calibration is successfully completed and required QC confirms acceptable performance.
Knowing when to stop external troubleshooting and escalate is proper troubleshooting.
Clinical Use Tip
Never use repeated calibration attempts as a substitute for identifying an unresolved reagent, fluidics, or analyzer problem.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported that calibration for an assay repeatedly failed on the DxC 700 AU."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the calibrator tube had insufficient usable volume for consistent aspiration."
Resolution
What action was taken.
Example:
"The calibrator was replaced with properly prepared material, calibration completed successfully, and subsequent QC was verified acceptable."
Helpful Details to Include (If Known)
- Assay affected
- Calibration failure message
- Reagent lot and status
- Calibrator lot and condition
- Calibrator preparation and volume
- Tube or cup condition
- Related aspiration or fluidics messages
- Whether multiple assays are affected
- Result of repeat calibration
- QC result after correction
Final Thought
Protect patient results first, then verify calibrator, reagent, sample presentation, and analyzer readiness before assuming an internal measurement problem. Escalate repeated failures and document both the cause and successful post-repair validation.
That is successful troubleshooting.