Donor Referral Services

FDA Public Health Notification Regarding Donor Referral Services
The FDA has notified the health-care community that human tissue recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. A donor is determined eligible to donate tissues only if the results of donor screening and donor testing indicate freedom from communicable diseases or communicable disease risks.

Below is the FDA Public Health Notification regarding Donor Referral Services

FDA Public Health Notification, August 31, 2006 – The Food and Drug Administration (FDA) is issuing this notification to inform the health care community that human tissues recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. This notification is a result of an ongoing FDA investigation of DRS which was located in Raleigh, NC, and at a former location in Las Vegas, NV. While no adverse reactions associated with these tissues have yet been reported, and subsequent processing should reduce the potential risks of infectious disease transmission, health care providers who were supplied with these tissues are being notified of the potentially increased risk for infectious disease transmission. FDA and the Centers for Disease Control and Prevention (CDC) are strongly recommending that health care providers inform their patients who received tissues initially recovered by DRS that they may have received tissue from donors for whom adequate donor eligibility determinations were not performed, and offer patients access to appropriate infectious disease testing.

Getting More Information
Additional questions may be directed to FDA's Center for Biologics Evaluation and Research at 1-800-835-4709 or by e-mail at octma@cber.fda.gov.

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