MalfunctionDAF
MDR event
Received Nov 13, 2008
Report 2250051-2008-00501 · MDR key 1269137
Device
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ORTHO CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAINED TESTING WITH ANTI-HUMAN GLOBULIN BIOCLONE. THE RESULTS OF THE RETAIN TESTING WERE SATISFACTORY. CUSTOMER TESTING WAS PERFORMED DURING VALIDATION TESTING OF THE REAGENT. PT RESULTS WERE NOT AFFECTED.