Tissue for Transplant Is Recalled After FDA Shuts Down N.C. Firm

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Associated Press
Wednesday, August 23, 2006

A leading medical firm has recalled hundreds of human-tissue products destined for transplants around the nation that were supplied by a North Carolina body-parts broker.

On July 6, AlloSource of Centennial, Colo., began a recall of about 300 transplant parts supplied by Donor Referral Services of Raleigh, N.C., an AlloSource spokeswoman said yesterday.

On Friday, the Food and Drug Administration shut down Donor Referral Services, saying the company, run by Philip Guyett, had "serious deficiencies" in its processing, donor screening and record-keeping.

The FDA refused to say how many people may have received potentially risky tissue.

It is the second scandal in less than a year in the booming but little-regulated tissue-transplant industry. Cadaver tissue is used in more than a million transplants each year in such routine operations as back surgery and knee repairs.

Improperly processed or poorly tested tissue can lead to illnesses such as hepatitis or AIDS, or even death. Last year, a scandal unfolded around Biomedical Tissue Services, a New Jersey company accused of using stolen bodies and of shipping potentially tainted body parts.