MalfunctionLOJ
ELECSYS AFP
Received May 22, 2026 · Event occurred Apr 28, 2026
Report 1823260-2026-02018 · MDR key 25256055
Device
Generic name
Kit, Test,alpha-fetoprotein For Testicular Cancer
Manufacturer
Roche DiagnosticsCatalog number
09015124190
Lot number
84632102
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW ELECSYS AFP ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 18.3 IU/ML. THE REPEAT RESULT WAS 35.9 IU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.