VITROS ECI IMMUNODIAGNOSTIC SYSTEM (RECERTIFIED)
Received Dec 22, 2008 · Event occurred Aug 29, 2008
Report 1319681-2008-00377 · MDR key 1349107
Device
Generic name
Immunodiagnostic System
Manufacturer
Ortho-clinical DiagnosticsModel number
NACatalog number
6801059
Lot number
NA
Product problems
- False Positive Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AN OCD RESEARCH AND DEVELOPMENT SCIENTIST OBTAINED A NON-REPRODUCIBLE FALSE POSITIVE VITROS ANTI-HBC RESULT ON THE VITROS ECI. THE SAMPLE WAS AN ANTI-HBC NEGATIVE SAMPLE THAT HAD BEEN PREPARED FROM A HUMAN SERUM POOL. PATIENT RESULTS WERE NOT AFFECTED AS THE TESTING WAS NOT PERFORMED IN A FACILITY THAT REPORTS PATIENT RESULTS FOR DIAGNOSTIC PURPOSES. THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.
Additional Manufacturer Narrative
THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT THE VITROS ECI OR THE VITROS ANTI-HBC REAGENT MALFUNCTIONED AT THE TIME OF THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE FALSE POSITIVE VITROS ANTI-HBC RESULTS.