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 SIMPLEXA HSV 1 & 2 DIRECT ASSAY. THIS ERROR MAY RESULT IN A FALSE POSITIVE RESULT, A FALSE NEGATIVE 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 MARCH 10, 2016, THERE HAS BEEN NO REPORT OF PATIENT INJURY OR DEATH.