SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK

Description of Event or Problem

FOCUS DIAGNOSTICS HAS RECEIVED A TOTAL OF 34 COMPLAINTS FROM 20 CUSTOMERS FOR EARLY CYCLE THRESHOLD (CT) ISSUES WITH THE DIRECT AMPLIFICATION DISC (DAD) (MOL1455, MOL1451, AND MOL 1452) WHILE PERFORMING THE (B)(4) DIRECT ASSAY. THIS ERROR MAY RESULT IN A (B)(6) RESULT, AND ERROR CODE(S) GIVING AN INVALID RUN. EARLY INTERNAL TESTING REPRODUCED THE EARLY CT THRESHOLD; HOWEVER, THESE EARLY CT WERE PRODUCED ONLY WHEN THE DAD WAS USED AFTER A PREVIOUS PARTIAL RUN. THE FALSE RESULT WAS NOT REPORTED TO THE DOCTOR. THERE WAS NO PATIENT INVOLVEMENT. A VOLUNTARY RECALL HAS BEEN PERFORMED RELATED TO THE REPORTED LOT. AS OF (B)(6) 2016, THERE HAS BEEN NO REPORT OF PATIENT INJURY OR DEATH.