MICROSCAN PROMPT INOCULATION SYSTEM-D

Description of Event or Problem

ACCOUNT REPORTED TO DADE BEHRING THAT THEY HAD INTERMITTENTLY OBSERVED INSUFFICIENT GROWTH (NO RESULTS) ON QC AND CLINICAL ISOLATES. ISSUE WAS ONLY ASSOCIATED WITH THE IDENTIFIED PROMPT LOT. ACCEPTABLE RESULTS WERE OBTAINED AFTER REPEATING THE TESTS. THERE WERE NO REPORTS OF INJURY OR ILLNESS ASSOCIATED WITH THIS ISSUE.

Additional Manufacturer Narrative

PERFORMANCE TESTING OF CUSTOMER RETURNS AND RETENTION SAMPLES. IN-HOUSE TESTING PERFORMED AND CONFIRMED INSUFFICIENT GROWTH ISSUE WITH CUSTOMER PROVIDED SAMPLES AND ALSO WITH RETENTION SAMPLES. DADE BEHRING HAS INITIATED A FIELD CORRECTION FOR THIS ISSUE AND NOTIFIED CUSTOMERS OF THE POTENTIAL FOR DISCREPANT MIC AND/OR IDENTIFICATION RESULTS WITH CLINICAL AND QC ISOLATES WITH THE IDENTIFIED PROMPT INOCULATION SYSTEM-D LOT.