ELECSYS FOLATE III
Received Feb 19, 2026 · Event occurred Feb 2, 2026
Report 1823260-2026-00591 · MDR key 24388215
Device
Generic name
Acid, Folic, Radioimmunoassay
Manufacturer
Roche DiagnosticsCatalog number
08324174190
Lot number
91120301
Product problems
- Failure to Recalibrate
- High Test Results
- High Readings
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E 402 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FOLATE III ON A COBAS PURE E 402 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A FOLATE VALUE OF > 20.0 NG/ML. THE SAMPLE WAS AUTOMATICALLY DILUTED 1:2 AND REPEATED, RESULTING IN A VALUE OF 12.4 NG/ML. THE SAMPLE WAS REPEATED AGAIN WITHOUT DILUTION, RESULTING IN A VALUE OF > 20.0 NG/ML. THE SAMPLE WAS REPEATED WITH AN ON-BOARD 1:2 DILUTION, RESULTING IN A FOLATE VALUE OF 11.0 NG/ML ON (B)(6) 2026. THE SAMPLE WAS MANUALLY DILUTED 1:2 AND REPEATED, RESULTING IN A RAW VALUE OF 6.29 NG/ML, WHICH CALCULATES TO A FINAL FOLATE VALUE OF 12.58 NG/ML ON (B)(6) 2026. A NEW REAGENT PACK WAS CALIBRATED AND THE SAMPLE WAS REPEATED WITHOUT DILUTION ON (B)(6) 2026, RESULTING IN A FOLATE VALUE OF 9.52 NG/ML. THE SAMPLE WAS ALSO DILUTED 1:2 ON-BOARD THE INSTRUMENT AND REPEATED, RESULTING IN A VALUE OF 8.05 NG/ML ON (B)(6) 2026. THE SAMPLE WAS REPEATED AGAIN USING THE OLDER REAGENT PACK AND IT RESULTED IN A FOLATE VALUE OF 17 NG/ML.