PHD 1X IFA/EIA SYSTEM

Description of Event or Problem

A PHYSICIAN CONTACTED THE USER FACILITY AFTER RECEIVING WHAT HE THOUGHT WERE INCORRECT RESULTS FOR (B)(6). THE PATIENTS WERE GREATER THAN 90% NEGATIVE. THE LITERATURE AND PRODUCT LABELING (INSTRUCTIONS FOR USE) HAVE AN EXPECTED POSITIVITY RATE OF 97-98%. THE LAB USES NON-TECHNICAL PERSONNEL PERFORMING THE TESTING AND A CLS HAD RELEASED THE RESULTS. THE LAB ROUTINELY PERFORMS (B)(6) TOGETHER. THE (B)(6) RESULTS DID NOT GENERATE ANY COMPLAINTS. THE READER AT THE CUSTOMER SITE WAS THE PR4100 MODEL. THE CUSTOMER PULLED SAMPLE RUN REPORTS ON THE SYSTEM FROM (B)(6) AND CONTACTED USSD TECHNICAL SUPPORT WITH SEVERAL SUSPECT RUNS AS WELL AS INDICATING THAT THE (B)(6) ASSAY WAS NOT ALWAYS PASSING VALIDATION RULES AND RESULTED IN ROUTINELY FAILING RUNS WITH NO RESULTS REPORTED. SAMPLES FROM PREVIOUS SUSPECT RUNS WERE AVAILABLE FOR REPEAT TESTING. WHEN THEY WERE REPEATED IN A (B)(6) ONLY RUN, WITHOUT (B)(6), THE RUN PASSED VALIDATION RULES AND THE (B)(6) RESULTS WERE GREATER THAN 90% POSITIVE.