{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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THE RESULTS ON SOME PATIENT ARE RUNNING REALLY HIGHER. PER FEEDBACK FROM THE PROVIDER, THE PATIENT WERE TAKING DIM SUPPLEMENT. IT IS NOT ON THE LIST OF SUPPLEMENTS ON THEIR INTERFERENCE LIST FOR THE ASSAY. WE TRIED CALLING THE VITROS CUSTOMER SUPPORT. WE EVEN DID SOME STUDY USING BLOCKING TUBES FOR RULING OUT HETEROPHILE ANTIBODY AND STILL THE SAMPLE WERE RUNNING HIGHER. ANALYTIC ERRORS WERE ALL RULED OUT (QC, CALIBRATION, INSTRUMENTS PERFORMANCE WAS GOOD). WE KNOW THERE IS AN INTERFERENCES WITH THE ASSAY BUT NOT SURE WHAT CAUSING IT. WE SEND THE LABS TO THE REFERENCE LAB FOR THOSE TEST. THEY WERE ALL WITHIN THE EXPECTED RANGES. WE ARE NO LONGER RUNNING THE TEST ON VITROS. WE SWITCHED TO SIEMENS ATELICA PLATFORM. I JUST WANTED TO LET FDA KNOW ABOUT THE ISSUE THAT WAY WE CAN START TROUBLESHOOTING ON WHAT MAY BE THE OTHER REASON CAUSING THIS ISSUES. THE RESULTS ON SOME PATIENT ARE RUNNING REALLY HIGHER ON FEMALE AND SOME PATIENTS, WE NOTICED ESTRADIOL BEING UPPER 1500 PG/ML. SOLARIS DIAGNOSTICS. FDA SAFETY REPORT ID # (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }