Description of Event or Problem · 0
GREETINGS, I AM A LONG TIME (MANY YEARS) BLOOD DONOR AND ONE BLOOD, THE DONOR ORGANIZATION HERE IN (B)(6), ROUTINELY TESTS MY DONATED BLOOD. MY DONATION WAS REJECTED IN THE PAST FEW MONTHS DUE TO A (B)(6) SYPHILIS TEST AND I HAD ANOTHER SAMPLE TAKEN RECENTLY TO CONFIRM IF THAT TEST WAS (B)(6). IT ALSO CAME BACK (B)(6). I HAVE DONATED FOR YEARS AND HAVE NOT HAD A (B)(6) SYPHILIS TEST IN THE PAST, BUT I DID RECENTLY HAVE THE THREE SHOT REGIMEN OF MODERNA'S COVID VACCINES. I LOOKED AT THE INTERNET AND FOUND THAT YOU HAVE RECENTLY SENT AN ADVISORY ABOUT A CROSS REACTION BETWEEN THE COVID VACCINE AND AN RPR SYPHILIS TEST: HTTPS://WWW.FDA.GOV/MEDICAL-DEVICES/LETTERS-HEALTH-CAREPROVIDERS/ POSSIBLE-FALSE-RPR-REACTIVITY-BIOPLEX-2200-SYPHILIS-TOTAL-RPR-TEST-KIT-FOLLOWING-COVID-19-VACCINE I BELIEVE THAT THIS MAY ALSO OCCUR WITH THE TEST USED ON MY BLOOD (SYPHILIS TREPONEMAL ANTIBODY TEST (MHA-TP) RUN BY CREATIVE TESTING SOLUTIONS, TEMPE, AZ). I WAS (B)(6) FOR THE CAPTIA SYPHILIS G EIA. I THOUGHT YOU SHOULD BE AWARE OF THIS ISSUE AND MAY WANT TO INVESTIGATE. BLOOD DONOR ORGANIZATIONS MAY BE TURNING AWAY ACCEPTABLE DONORS DUE TO CROSS REACTIVITY IN THE SYPHILIS TESTS. IF YOU WOULD LIKE MORE INFORMATION OR WOULD LIKE TO DISCUSS THIS MORE, FEEL FREE TO CONTACT ME. ALL THE BEST, (B)(6). FDA SAFETY REPORT ID #:(B)(4).