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