Although the FDA may not "swoop down" on reporting Transfusion Services, administraters are sometimes reluctant to report errors; possibly in fear of showing up on FDA radar. My administrative director once told me that, if I reported anything to the FDA, it would affect my position in the company. I established a policy that required all errors be reported to administration and the blood bank director and they would make the decision to report or not. I visited my old blood bank after I retired and my replacement asked if I wanted my job back. I felt sorry for her. MT,(ASCP) retired (thankfully)