A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE DATA GENERATED DURING LOT TO LOT CORRELATIONS FOR THE ACTIVE INHIBIN A ELISA METHODOLOGY DID NOT MEET THE LABORATORY'S EXPECTATION CRITERIA. THE CUSTOMER INDICATED THAT THE LOT IS EXHIBITING A POSITIVE BIAS WHEN COMPARED TO OLDER LOT SAMPLES RECOVERIES. CUSTOMER INDICATED COMPARISON DATA DID NOT MEET OWN COMPARISON DATA EXPECTATION CRITERIA WITH PATIENT SAMPLES DEMONSTRATING AN AVERAGE INCREASE OF 23% ACROSS FIVE (5) SAMPLES WHEN USING THE NEW REAGENT LOT COMPARED TO AN OLDER LOT. THE CUSTOMER ALSO INDICATED THAT THE COMPARISON ASSAY ANALYSIS WAS PERFORMED ON MULTIPLE DAYS AND NOT A TRUE SIDE BY SIDE ANALYSIS. THE STUDIES DID NOT INCLUDE ANY PATIENT SAMPLES THAT WERE USED FOR REPORTING. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.
N
Patient 1
SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS NOT SUPPLIED. SAMPLE STORAGE INCLUDING CONDITIONS FOR TIME FRAME BETWEEN LOT CORRELATION EVALUATIONS WAS NOT SUPPLIED. ASSAYS WERE PERFORMED ON A MANUAL ELISA ASSAY PLATFORM. QC DATA POINTS IDENTIFIED THAT THE QC RECOVERY WAS WITHIN THE ESTABLISHED RANGES. CUSTOMER'S INTERNAL POOL CONTROL (MMS) RECOVERIES ARE OUTSIDE LABORATORY'S ESTABLISHED RANGE HIGH IN ALL THE ASSAY RUNS SUPPLIED. SYMPTOM REPORTED IS RELATIVE TO CUSTOMER'S EXPECTATIONS OF % DIFFERENCE BETWEEN LOTS WHICH WAS NOT RELATED. INTERNAL INVESTIGATION IS PENDING TO DATE, AND NO CLEAR ROOT CAUSE HAS BEEN DETERMINED THUS FAR.