Description of Event or Problem · 1
BIO-RAD LABS TECHNICAL SUPPORT REC'D A CALL IN 2007, REGARDING A DISCREPANCY OF CORRELATION RESULTS FOR ONE TEST SAMPLE. ASSAYS USED FOR THE CORRELATION STUDY WERE THE BIO-RAD GENETIC SYS HIV-1/HIV-2 PLUS O EIA KIT AND THE BIOMERIUX VIRONOSTIKA HIV-1 MICROPLATE ASSAY KIT. THE TEST RUN WITH THE BIO-RAD GENETIC SYS HIV-1/HIV-2 PLUS O EIA KIT WAS PERFORMED USING A FOUR PLATE SYS CALLED THE EVOLIS. THE INITIAL RUN ON ONE SAMPLE USING THE BIO-RAD GENETIC SYS HIV-1/HIV-2 PLUS O EIA KIT ON THE EVOLIS WAS NON-REACTIVE. THE SAME SAMPLE TESTED ON THE BIOMERIEUX VIRONOSTIKA HIV-1 MICROPLATE ASSAY KIT PRODUCED A REACTIVE RESULT. BASED ON THE REACTIVE BIOMERIEUX VIRONOSTIKA HIV-1 MICROPLATE ASSAY, THE CUSTOMER RE-RAN SAMPLE USING THE BIO-RAD GENETIC SYS HIV-1/HIV-2 PLUS O EIA KIT ON THE EVOLIS AND THE RESULT WAS REACTIVE. IN ADDITION TO PROVIDING FINAL EIA TEST RESULTS, THE CUSTOMER ALSO PROVIDED INFO REGARDING AN IN-PROCESS SAMPLE VERIFICATION STEP, WHICH IS A FEATURE OF THE EVOLIS. THAT IS, THE EVOLIS MEASURES THE OPTICAL DENSITY (OD) OF EACH WELL FOLLOWING KEY STEPS, INCLUDING SAMPLE ADDITION. THE OD AFTER THE SAMPLE ADDITION STEP WAS LOWER THAN THE OTHER SAMPLES ON THE SAME PLATE, STILL PASSING THE EXISTING OD CRITERIA. THE CUSTOMER WAS NOT ABLE TO PROVIDE BIO-RAD LABS FOR INVESTIGATION WITHIN THE 30 DAY MDR REVIEW. WHEN THE SAMPLE IS REC'D, ADD'L INVESTIGATIONAL TESTING WILL BE PERFORMED TO DEFINE ROOT CAUSE AND CORRECTIVE ACTIONS AS APPLICABLE TO ADDRESS THIS OCCURRENCE.