MINIVIDAS INSTRUMENT

Description of Event or Problem

TEH MINIVIDAS ISNTRUMENT IS A DISCRETE WAVELENGTH FLUOROMETER. THE INSTRUMENT HAS 5 SECTIONS WITH 6 POSITIONS PER SECTION. THE POSITIONS OPERATE MECHANICALLY INDEPENDENT OF EACH OTHER. THE CUSTOMER REPORTED THAT SINCE JANUARY 2005 ALL OF THEIR TESTS IN POSITION A6 HAVE BEEN NEGATIVE WHICH THE CUSTOMER SAYS IS UNUSUAL. BIOMERIEUX DISTRIBUTES AND INSTRUCTS CUSTOMERS TO USE A QC TEST, QCV (QUALITY CONTROL VIDAS) MONTHLY. THIS CUSTOMER HAD NOT BEEN RUNNING THE QCV TEST. THE CUSTOMER IS NO LONGER COOPERATING WITH BIOMERIEUX, HOWEVER, NO REPORTS OF FALSE RESULTS HAVE BEEN MADE. BIOMERIEUX HAS ASKED THE CUSTOMER TO PERFORM A RETROSPECTIVE ANALYSIS OF THE RESULTS FROM POSITION A6 TO CONFIRM THIS, HOWEVER, THE CUSTOMER HAS NOT COMMUNICATED THE RESULTS OF THE RETROSPECTIVE ANALYSIS TO BIOMERIEUX.