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Dear madam or sir fda doctors, this is to ask you to pull the cologuard kit's fda authorization until exact sciences develops science to work when normal rectal bleeding and hemorrhoids are present and their clinical trial test results are much better than 13% false positive and 8% false negative.If you can not or will not do that please send out a warning to doctors and hospitals they must warn patients immediately after suggesting cologuard the false positive and negatives are lousy.And have exact sciences put a warning on the side of the cologuard box and that commercial streaming on tv this test will not work with hemorrhoids, rectal bleeding and in clinical trials has a lousy 13% false positive and 8% false negative that could cause you to have an unnecessary, reckless colonoscopy procedure that could punch through your colon and kill you.On (b)(6) 2021 i sent a letter to exact sciences chief compliance officer when i returned the unused cologuard kit.I got snail mail letter 28 sept 2021 to call their 800#.I called they had no record of the letter i enclosed with the unused kit.I got an exact sciences letter after my primary physician or gastrointestinal ordered the kit cologuard has an error rate of 13% false positive and 8% false negative.The collection kit makes it difficult if not impossible to collect a sample, if there is rectal bleeding as a result of hemorrhoids which i have occasionally.It is not unusual, it is common because the blood vessels are close to the surface of the colon and they break.A false positive reading as a result of 13% error or blood in the sample would be dangerous for me because someone might think i need a colonoscopy.I have a elongated colon, they only allow 25 minutes per procedure it would be incomplete and they would want to do a complex coloscopy; 2 unnecessary procedure with danger of scope punch through the colon, 2 sedations, 2 invasive procedures, why would i want to consent? i had a colonoscopy at age (b)(6) no polyps, i am (b)(6).I imagine it is easier to punch through my colon now that i am older punch through danger was in the informed consent the nurse asked me to sign when i was (b)(6) after fasting even though i asked for any documents to sign prior to the procedure so i could read everything.When i had the procedure done at (b)(6) there were concerns colonoscopes were not getting properly cleaned and some had become infected with aids.I have 10 years of negative fit tests.Thank you for reading this complaint and acting on it.Thank you for your oversight.(b)(6).Dear cologuard chief compliance officer, i am returning the cologuard kit unused because i have rectal bleeding, i think the clinical trials 13% false positive rate is high, i have 10 years of negative fit tests from 2011 to 2021.I do not want a false positive cologuard test result to trigger a colonoscopy.The demerol and midazolam make me forget the procedure, nauseous and a nasty headache.I have an elongated colon, they schedule a 1/2 -hour colonoscopy procedure per patient which is not enough time for my elongated colon.My previous colonoscopy showed no polyps and bleeding was a result of internal hemorrhoids.I think a colonoscopy now is risky, unnecessary and would probably be incomplete due to my elongated colon.I am scared of punching through with the endoscope and i do not want a false positive or blood from my hemorrhoids to trigger an inconclusive or false positive cologuard test result.For these reasons and no symptoms of colon cancer i would not provide consent for a colonoscopy at this time if a cologuard test were false positive or inconclusive.Please respect my hippa rights with regard to the enclosed attachments but i want to share this to provide accurate feedback to help spawn any improvements you care to make with your kit or educating doctors that recommend your kit.I like your cologuard commercials on streaming tv, especially the little box guy in the recliner at the beach.Thank you, (b)(6), (b)(6) 2021.Fda safety report id# (b)(4).
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