The fine was a result of an FDA finding that the Red Cross washed six units of red blood cells with hypertonic saline solution instead of the sterile normal saline solution. The blood cells were transfused to three patients in 2006 and 2007 at three Red Cross chapters in the Northeast and Southeast.
Eva Quindley, senior vice president for quality and regulatory affairs of the Red Cross, said despite the error, the patients' lives were not placed in danger and no negative effects were reported.
FDA spokeswoman Peper Long assured the public it should not panic over the incident. Even as the FDA said the problem was serious, Long pointed out the American Red Cross was trying to address the problem.
This was the first time that FDA fined the Red Cross. In September 2006 Red Cross was penalized $4.2 million for non-compliance with federal and FDA regulations concerning the collection of blood products. In February 2008 another $4.6 million fine was slapped on the Red Cross after the FDA discovered 113 incidents in which the organization collected blood from an ineligible donor, failed to undertake proper testing or shipped the collected blood at wrong temperature.
Over the past five years it has been fined over $21 million for lapses in safety procedures. Long clarified to the Washington Post, "The organization certainly has made progress, but we are still seeing errors. And the problems are certainly serious, and they need to be addressed."
