MICROSCAN PROMPT INOCULATION SYSTEM-D

Description of Event or Problem

ACCOUNT REPORTED TO DADE BEHRING THAT THEY HAD OBSERVED INSUFFICIENT GROWTH (NO RESULTS REPORTED) WITH SOME S. AUREUS AND OTHER STAPH. ISOLATES. ACCOUNT INDICATED THAT THEY DID NOT REPORT THE OBTAINED RESULTS. ISSUE WAS ONLY ASSOCIATED WITH THE IDENTIFIED PROMPT LOT. 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.