MalfunctionMKW
CYCLOSPORINE CALIBRATOR
Received Dec 12, 2023 · Event occurred Dec 5, 2023
Report MW5149187 · MDR key 18319230
Device
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ABBOTT ARCHITECT CYCLOSPORINE REAGENT AND CALIBRATOR INCOMPATIBILITY. REAGENT DID NOT CALIBRATE, AND MANUFACTURER COULD NOT SUPPLY SUITABLE REPLACEMENT PRODUCT AND OFFERED NO RESOLUTION. THE QUALITY MANAGEMENT SYSTEM OF IVD MFRS MUST INCLUDE TESTING AND ASSURANCE THAT REAGENTS AND CALIBRATORS ARE COMPATIBLE AND ARE ABLE TO YIELD SUCCESSFUL OUTCOMES.