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Manufacturer
Model
What This Guide Helps With
Troubleshooting failed QC, failed calibration checks, strip read concerns, or lockout conditions caused by external or maintenance-related issues.
Step-by-Step Troubleshooting
Ensure Patient Safety First
Confirm the CLINITEK Status+ is not being used for active patient testing.
If QC has failed or the analyzer is locked out, direct staff to use another approved analyzer or follow laboratory downtime procedure.
Expected outcome: No patient results are generated from a device with unresolved QC or calibration concerns.
Verify the Reported Issue
Confirm whether the complaint is:
- QC result out of range
- Calibration check failure
- QC lockout
- Repeated strip read error
- Unexpected positive or negative QC result
- Operator unable to proceed with patient testing
Expected outcome: The failure type is clearly identified before troubleshooting.
Check Power Stability
Verify the analyzer is connected to a known-good outlet or has adequate battery power.
If using the power supply, inspect the adapter and connection for looseness or damage.
Expected outcome: The analyzer powers on normally without low-battery warnings or intermittent shutdowns.
If power instability is corrected and QC passes, return the device to service and stop.
Confirm Correct QC Material Was Used
Verify staff used the correct urine chemistry QC material for the strip type being tested.
Check the QC level, lot number, expiration date, storage conditions, and whether the control was mixed/prepared per lab policy.
Expected outcome: QC material is correct, in date, properly stored, and appropriate for the test strip.
Why it matters: Expired, contaminated, poorly mixed, or incorrect QC material is a common cause of QC failure.
Confirm Correct Test Strips Were Used
Verify the strips are Siemens-compatible and appropriate for the CLINITEK Status+ analyzer.
Check strip lot number, expiration date, bottle condition, and whether the cap was left open.
Siemens notes that the CLINITEK Status+ is designed for Siemens urine strips and includes Auto-Checks for strip identification, humidity exposure, and common sample interferences.
Expected outcome: Test strips are correct, dry, in date, and stored properly.
If a new valid strip bottle resolves the QC failure, document the defective or compromised strip bottle and stop.
Inspect the Test Table and Insert
Remove the test table and insert only as allowed for routine operator-level cleaning.
Look for dried urine, QC residue, strip fragments, paper fibers, staining, or buildup on the test table path.
Clean the test table and insert according to facility procedure and manufacturer cleaning guidance. Siemens provides routine maintenance guidance for cleaning the test table and insert.
Expected outcome: The test table and insert are clean, dry, fully seated, and move freely.
Inspect the White Calibration Bar
Inspect the white calibration bar on the test table for contamination, discoloration, scratches, residue, or damage.
Clean only with approved methods. Do not scrape, polish, mark, or use harsh chemicals.
Expected outcome: The calibration bar is clean, intact, and free of visible residue.
Why it matters: The analyzer performs automatic calibration during testing, and a dirty or damaged calibration area can affect calibration and strip reading. A CLINITEK Status user manual notes that the analyzer performs automatic calibration each time a test is run and warns not to move or bump the table during the process.
Verify the Test Table Is Properly Installed
Reinstall the test table and insert carefully.
Confirm the table is fully seated, aligned, and not obstructed.
Start a test cycle without forcing or manually moving the table.
Expected outcome: The analyzer accepts the table position and completes the cycle without table or calibration-related errors.
Check for Analyzer Movement During Testing
Ask whether the device was moved, bumped, tilted, or handled while QC was running.
Place the analyzer on a level, stable surface away from sinks, vibration, centrifuges, carts, or heavy traffic.
Expected outcome: QC is repeated with the analyzer stationary throughout the full test cycle.
If the analyzer passes QC on a stable surface, return it to service and document the environmental cause.
Confirm Proper QC Test Technique
Observe or review the QC process with the operator or POCT coordinator.
Confirm that:
- The correct QC mode was selected
- The strip was dipped or dosed correctly
- Excess liquid was removed per procedure
- The strip was placed promptly and correctly on the test table
- The strip pads faced the correct direction
- The test was started at the correct time
- The strip was not over-saturated or allowed to dry
Expected outcome: QC testing is performed consistently and correctly.
Repeat QC With Fresh Materials
Repeat QC using:
- Fresh QC material, if available
- A new strip from a valid bottle
- A clean, dry test table
- Stable power
- A level surface
Expected outcome: QC passes with fresh materials and proper technique.
If QC passes, return the analyzer to service according to POCT/lab policy and document the external cause.
Review QC Lockout or Operator Settings
If the analyzer is connected to a CLINITEK Status Connect or POCT management system, verify whether patient testing is blocked due to QC lockout, expired operator certification, expired strip lot, or expired QC lot.
Coordinate with the POCT coordinator or lab administrator before changing any settings.
Expected outcome: Lockout status is understood and corrected through approved POCT workflow.
Why it matters: Some failures are not mechanical faults; they are compliance lockouts designed to prevent patient testing until QC requirements are met.
Check Date and Time
Verify the analyzer date and time are correct.
Incorrect date/time can make valid QC, strip, operator, or lot information appear expired.
Expected outcome: Date and time match facility standard.
Review Error Messages and Printed/Displayed Results
Record the exact error message, QC result, analyte failure, lot number, operator ID, and time of failure.
Look for trends such as one QC level failing, one analyte failing, all strips failing, or failures only with one operator.
Expected outcome: The issue is narrowed to material, technique, configuration, or analyzer behavior.
Perform a Final Functional Check
After cleaning and correcting external causes, repeat QC according to facility policy.
Do not return the analyzer to patient testing unless QC passes and the device meets POCT/lab release requirements.
Expected outcome: Analyzer passes required QC and is cleared for use.
If the Problem Persists
If QC or calibration check failures continue after confirming power, strips, QC material, test table cleanliness, calibration bar condition, operator technique, date/time, and lockout settings, common external causes have been ruled out.
The issue may involve an internal optical, calibration, test table sensing, software, or analyzer hardware problem.
The device should be:
- Removed from service
- Labeled Out of Service
- Sent for repair, bench evaluation, or Siemens-supported service review
Knowing when to stop is proper troubleshooting. Do not continue patient testing on a urine analyzer with unresolved QC or calibration failure.
Clinical Use Tip
Do not troubleshoot QC or calibration failures while patient testing is waiting on that device. Move testing to another approved analyzer or follow downtime procedure first. QC failure means the analyzer has not demonstrated acceptable performance for patient result reporting.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Clinical staff reported the CLINITEK Status+ failed urine chemistry QC and would not allow patient testing."
Cause
What was observed during troubleshooting.
Example:
"Test table and white calibration bar were found with dried residue, and the strip bottle in use had been left open near the testing area."
Resolution
What action was taken.
Example:
"Cleaned and dried the test table assembly, verified correct installation, replaced strips with a valid closed bottle, repeated QC successfully, and returned analyzer to service per POCT approval."
Helpful Details to Include (If Known)
- Outlet or battery status checked
- Power supply condition
- Exact QC failure or calibration message
- QC level and lot number
- Strip lot number and expiration date
- Strip bottle condition
- QC material expiration and storage condition
- Test table cleaned
- White calibration bar inspected
- Analyzer surface level and stable
- Operator technique observed
- Lockout status reviewed
- Date and time verified
- Final QC result
- Final device status
Final Thought
QC and calibration issues should be handled carefully because they directly affect patient result reliability. Start with the external causes that are most likely and easiest to verify: strips, QC material, cleaning, calibration bar condition, power, surface stability, and operator workflow. If those checks do not resolve the issue, remove the analyzer from service and escalate appropriately. Clear CCR documentation protects both the patient and the troubleshooting process.
That is successful troubleshooting.