ALBUMIN BCP
Received Oct 22, 2025 · Event occurred Jun 11, 2024
Report 1823260-2025-04294 · MDR key 23359666
Device
Generic name
Bromcresol Purple Dye-binding, Albumin
Manufacturer
Roche DiagnosticsCatalog number
05599261190
Lot number
788349
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE BALL BEARINGS OF THE SAMPLE PIPETTOR WERE WORN AND REPLACED IT. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN BCP RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE DOCTOR QUESTIONED THE LOW INITIAL RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE INITIAL RESULT WAS 1167 MG/DL. THE REPEAT RESULT WAS 4331 MG/DL.