COMBUR 10
Received Nov 12, 2025 · Event occurred Oct 20, 2025
Report 1823260-2025-04597 · MDR key 23532134
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsCatalog number
09587624190
Lot number
84639701
Product problems
- False Negative Result
- Incorrect Measurement
- False Negative Result
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ROCHE DIAGNOSTICS INITIATED A ROOT CAUSE INVESTIGATION. IT WAS FOUND THAT ONE OF THE THREE EXPECTED STRIP LAYERS WAS MISSING FROM THE COMBUR10 TEST M STRIP LOT 84639701. THEREFORE, THE EXPECTED COLOR FOR LEUCOCYTES CANNOT DEVELOP, AND THE COBAS U 411 WILL DISPLAY A FALSE NEGATIVE RESULT FOR A POSITIVE SAMPLE. THE US IS NOT IMPACTED BY THE ISSUE DESCRIBED WITH COMBUR10 TEST M STRIP LOT LOT 84639701.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE COMBUR 10 LEUKOCYTE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES ON A COBAS U 411 URINE ANALYZER. THE TEST STRIPS SHOW NO SIGNS OF LEUKOCYTES, EVEN THOUGH LEUKOCYTES ARE MASSIVELY PRESENT (> 100 LEUKOCYTES/UL) UNDER THE MICROSCOPE.