MalfunctionJJE
HORIBA PENTRA C400
Received Mar 25, 2026 · Event occurred Oct 1, 2025
Report MW5185819 · MDR key 24688213
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Horiba Abx SasModel number
PENTRA C400Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MULTIPLE FAILURES OF HEMOGLOBIAN A1C RESULTING FROM THE HORIBA PENTRA C400. CONTINUALLY HIGH RESULTS WITH NO RESOLUTIONS FROM THE MANUFACTURER.