We are informing you that the FDA has announced their withdrawal of Guidance for ZIKV Testing. In their announcement, FDA indicated the Zika virus (ZIKV) is no longer a relevant transfusion-transmitted infection (RTTI) under FDA’s regulations, and the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population. Accordingly, the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018, has been withdrawn. Since ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV. FDA further advised that licensed blood establishments that discontinue testing blood donations for ZIKV must report this change to FDA in the annual report under 21 CFR 601.12(d), noting the date testing was discontinued. We are aware that our clients need information regarding the transition plans at CTS to inform their change group to cease ZIKV testing. We are forming a project team beginning today to evaluate the requirements for all stakeholders involved to define the requirements and timeline to eliminate ZIKV as a required donor panel test. We will provide an update with more information next week, but clients can begin plans to cease ZIKV testing.
IPFA welcomes Marion Lanteri as Executive Board member, CTS as new member organization
As a friendly reminder, airlines often change their routine flights and cargo hours for hol...
As a friendly reminder, airlines often change their routine flights and cargo hours for holidays. We...
As winter weather continues to move through parts of the US, we would like to remind you it may be n...
This is the first update to the original CTS communication distributed on July 6th. As previously co...
CTS originally communicated that Tampa will convert from the current Grifols Ultrio Plus NAT triplex...