Which of the following would require that a biological product deviation be reported to the FDA?

This version of the course is no longer available.

Need multiple seats for your university or lab? Get a quote

The page below is a sample from the LabCE course Current Good Manufacturing Practices for Transfusion Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Current Good Manufacturing Practices for Transfusion Services (online CE course)

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.