THE CUSTOMER HAS OBTAINED FALSELY LOW RESULTS ON TWO PATIENT SAMPLES FOR ESTRADIOL ON AN IMMULITE 1000 INSTRUMENT. PATIENT SAMPLE 1 WAS RUN NEAT AND AT A 1:5 DILUTION TWICE. PATIENT SAMPLE 2 WAS RUN NEAT AND AT A 1:2 DILUTION TWICE. IN BOTH INSTANCES THE FIRST RESULT OBTAINED ON PATIENT SAMPLE 1 AT THE 1:5 AND THE FIRST RESULT OBTAINED ON PATIENT SAMPLE 2 AT THE 1:2 DILUTION WERE FALSELY LOW. THE DILUENT LOTS USED FOR THE INITIAL FALSELY LOW DILUTED RESULT WAS DIFFERENT THAN THE DILUENT LOT USED FOR THE REPEAT RESULT ON BOTH THE PATIENTS SAMPLES. THE NEAT AND THE DILUTED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S), THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW ESTRADIOL RESULTS.
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Patient 1
THE CUSTOMER OBTAINED FALSELY LOW RESULTS ON TWO DILUTED PATIENT SAMPLES FOR ESTRADIOL ON AN IMMULITE 1000 INSTRUMENT. DUE TO THE RESULTS OBTAINED THE CUSTOMER USED A NEW LOT OF DILUENT, REDILUTED THE PATIENT SAMPLES AND THE VALUES OBTAINED ON THE IMMULITE 1000 WERE ACCEPTABLE BY THE CUSTOMER. THE CAUSE OF THE FALSELY LOW ESTRADIOL RESULTS ON THE TWO PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.