The Food and Drug Administration said five donors either had a sepsis diagnosis or showed clinical signs of sepsis. But the Indiana Lions Eye Bank countered that blood cultures from all five tested negative. “There is still only one gold standard for the diagnosis of sepsis, and that is a positive blood culture,” it said.
Fed. Judge Approves Settlement, Fees Against St. Louis Firm’s Data Breach
U.S. Magistrate Judge John M. Bodenhausen of the Eastern District