IMMULITE/IMMULITE 1000 CORTISOL

Additional Manufacturer Narrative

SIEMENS HAS CONFIRMED THAT IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS 381, 382, AND 383 DEMONSTRATE A POSITIVE BIAS WITH PATIENT SAMPLES IN THE RANGE OF APPROXIMATELY 13% TO 40%. THE POSITIVE BIAS WAS ALSO OBSERVED IN QUALITY CONTROL MATERIALS AND MAY RESULT IN VALUES OUTSIDE THE ESTABLISHED RANGES. THE ISSUE HAS BEEN RESOLVED WITH IMMULITE/IMMULITE 1000 CORTISOL KIT LOTS 384 AND ABOVE. AN URGENT MEDICAL DEVICE RECALL UMDR2014-09-19 WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) 1111, WAS SENT TO OUS CUSTOMERS IN SEPTEMBER OF 2014. THE UMDR AND UFSN STATE THAT CUSTOMERS ARE REQUESTED TO DISCONTINUE USE OF AND DISCARD THE IMMULITE/IMMULITE 1000 CORTISOL KITS LISTED, AND TO REVIEW THE UMDR/UFSN WITH THEIR MEDICAL DIRECTOR.

Description of Event or Problem

THE CUSTOMER HAS OBSERVED HIGH BIAS RESULTS ON TWO LEVELS FOR BIORAD QUALITY CONTROL SAMPLES WHEN USING THE CORTISOL ASSAY REAGENT LOT 382 ON AN IMMULITE 1000 SYSTEM. THE DATA OBTAINED WAS EITHER OUTSIDE OR AT THE UPPER LIMIT OF THE ACCEPTABLE RANGE. THE CUSTOMER DID NOT REPORT ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH BIAS OBSERVED ON THE BIORAD QUALITY CONTROL SAMPLES.