MalfunctionCGN
ELECSYS FOLATE III
Received Mar 11, 2026 · Event occurred Feb 16, 2026
Report 1823260-2026-00868 · MDR key 24570671
Device
Generic name
Acid, Folic, Radioimmunoassay
Manufacturer
Roche DiagnosticsCatalog number
08324174190
Lot number
91120302
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FOLATE III RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.7 NMOL/L. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED USING SIEMENS ATELLICA, AND THE RESULT WAS 13.5 NMOL/L.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED FOR FURTHER INVESTIGATION. THE INVESTIGATION IS ONGOING.