CALLER ALLEGING RECEIVING A FALSE NEGATIVE ON ICON 25 HCG, ONE LOT/PT, URINE SAMPLE. THE CUSTOMER STATES THAT SHE HAD ICON 25 PREGNANCY TEST THAT WAS PERFORMED ON A PT GOING INTO SURGERY AND WAS NEGATIVE. THE CUSTOMER STATES THAT IT WAS FOUND THAT THE PT WAS 12 WEEKS PREGNANT WITH TWINS AFTER THE SURGERY WAS PERFORMED. IT IS UNK WHAT SURGERY WAS PERFORMED. ON FOLLOW-UP, THE CUSTOMER STATED THAT THE SURGERY HAD NO NEGATIVE AFFECT TO THE PT/PREGNANCY. NO REPORT OF ADVERSE PT SEQUELA. NO ADDITIONAL INFO PROVIDED.
N
Patient 1
CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH 3 HIGH LEVEL HCG URINE CONTROLS. ALL RESULTS WERE POSITIVE AT READ TIME. NO FALSE NEGATIVES WERE OBTAINED. PT WAS 12 WEEKS PREGNANT AND MAY HAVE HAD VERY HIGH LEVELS OF HCG. HOOK EFFECTIVE CANNOT BE RULED OUT AS A CAUSE FOR THE FALSE NEGATIVE. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED WITHOUT PT SPECIMEN IN-HOUSE ANALYSIS. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. AS THERE IS NO INDICATION OF A PRODUCT DEFICIENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.