THIRD WAVE CFTR INPLEX AMPLIFICATION REAGENTS

Description of Event or Problem

THE LAB INDICATED THAT 2 FALSE POSITIVE RESULTS (A HET CALL FOR THE R347P AND 3849-10KB ASSAYS) WERE REPORTED TO THE ORDERING PHYSICIANS. UPON RETESTING OF DNA FROM THE ORIGINAL SAMPLES, THE RESULTS REPORTED ON 2/15/06 WERE DISCOVERED TO HAVE BEEN FALSE-POSITIVE AND THE PHYSICIANS WERE NOTIFIED BY THE LAB USING AMENDED REPORTS AND BY TELEPHONE. THE FALSE POSITIVE RESULTS WERE USED FOR PT COUNSELING WHICH LED TO THE PHYSICIAN ORDERING A CF CARRIER SCREENING TEST ON A PT'S SPOUSE. THE LAB RECEIVED THE BLOOD SPECIMEN BUT TESTING WAS CANCELLED BEFORE RESULTS WERE OBTAINED.