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Current Good Manufacturing Practices for Transfusion Services
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Which of the following would require that a biological product deviation be reported to the FDA?
Please select the single best answer
Failure to initial a quality control record.
Two units of Red Blood Cells crossmatched using the wrong patient specimen but were not issued from the blood bank.
A Plasma unit that broke in the water bath.
A unit of Red Blood Cells that was not signed out of the laboratory in the computer system.
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