WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe, officials said on Friday.
The fine, the largest ever levied by the Food and Drug Administration for a blood safety violation, follows a multiyear battle between the FDA and the Red Cross, which collects about 45 percent of the blood donated in the United States each year for transfusions.
The agency said it had no evidence that any blood collected by the Red Cross harmed people who got transfusions.
But FDA officials said the failure to follow multiple safeguards increased the risk that patients could receive blood tainted by an infectious disease.
"It is not acceptable that the quality systems failed in this way," Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs, told reporters.
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Monday, September 11, 2006