MalfunctionKZS
MDR event
Received Nov 21, 2006
Report 1056600-2006-00501 · MDR key 788465
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ORTHO-CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED RETAIN TESTING TO CONFIRM THE REACTIVITY OF THE FYB ANTIGENS. SATISFACTORY RESULTS WERE OBSERVED.