Location out of bounds
Radial
Radial

Newsroom

Resources for journalists

All Press Releases
Versiti Logo

FDA Accepts New Language For “Circular of Information for the Use of Human Blood and Blood Components”

Heartland Blood Center – November 3, 2017

AABB has updated its “Circular of Information for the Use of Human Blood and Blood Components” web page following the FDA’s approval for new language to be inserted in the November 2013 Circular. The updates have been made to provide the approved statement regarding the newly licensed Zika virus (ZIKV) nucleic acid test (NAT). The updated language is intended for use with blood products that have been tested for ZIKV using an FDA-licensed test. In such cases, the FDA requires the insertion of the following language:

  • “A licensed nucleic acid test (NAT) for Zika Virus RNA has been performed and found to be nonreactive.”

This language, developed by the Circular of Information Task Force and accepted by FDA, is similar to that required for other licensed NAT tests.

The insertion of this language is not required for blood products that have been tested for ZIKV under an Investigational New Drug (IND). In such cases, language provided by the IND sponsor remains unchanged.
AABB recommends the use of an adhesive label or an ink stamp to insert the updated language into the Circular. In addition, the version date of November 2013 will not change with this language insertion.

Contact Us

Fay Spano

Director, Public Relations and Corporate Communications
Email (414) 937-6124

Other Press Releases

Donate blood and win ultimate Chicago-Green Bay game day experience

August 13, 2019

Versiti Blood Center of Illinois Union Station Summer Blood Drive Wednesday, Aug. 21.

Read More
A proclamation by Indianapolis Mayor Joseph Hogsett dedicates Friday, Aug. 2, as Versiti Beacon of Hope Blood Donor Day.

Versiti's Beacon of Hope Blood Donors Day in Indiana

August 1, 2019

A mayoral proclamation dedicates Friday, April 2, as Versiti’s Beacon of Hope Blood Donors Day, marking the celebration of our new name and donor center design.

Read More
2019 Imagine Gala Program Cover

Versiti's Blood Research Institute Foundation to host third annual Imagine Gala

July 31, 2019

Versiti’s Blood Research Institute Foundation announced that it will host its third annual Imagine Gala on Friday, Sept.13, at the Wisconsin Club, 900 W. Wisconsin Ave., in Milwaukee.

Read More
ic-arrow-right
x

This website uses cookies to ensure you get the best experience on our website. Learn more