TOTAL PROTEIN GEN.2
Received Feb 5, 2026 · Event occurred Jan 16, 2026
Report 1823260-2026-00407 · MDR key 24270486
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsCatalog number
03183734190
Lot number
918360
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO FURTHER DATA OR INFORMATION WAS PROVIDED FOR THE INVESTIGATION. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR TOTAL PROTEIN GEN.2 (TP2) ON A COBAS 6000 C501 MODULE. OF THE DATA PROVIDED, THE RESULTS FOR 1 PATIENT SAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS 7.5 G/DL. THE REPEAT RESULTS WERE 8.6 G/DL AND 8.2 G/DL.
Additional Manufacturer Narrative
THE C501 MODULE SERIAL NUMBER WAS (B)(6). MAINTENANCE ACTIONS WERE PERFORMED, INCLUDING AIR PURGES, PROBE WASHING, AND PREPARING NEW QC AND CALIBRATION MATERIALS. THE ISSUE WAS NOT RESOLVED. THE REAGENT WAS REPLACED, AND QC WAS ACCEPTABLE; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE INVESTIGATION IS ONGOING.