Centennial-based AlloSource said Wednesday it is handling the recall of a batch of possibly tainted tissue supplied by a Raleigh, N.C.-based body-parts broker under investigation by the U.S. Food and Drug Administration.
AlloSource is a nonprofit that processes and distributes human-tissue products used in medical procedures.
The AlloSource recall, which began in July and should be completed in September, involves 312 pieces of tissue distributed by U.S. Tissue & Cell, a Cincinnati-based nonprofit, said Tom Cycyota, president and chief executive of AlloSource.
AlloSource in March acquired certain assets of U.S. Tissue & Cell, which was a client of Raleigh-based Donor Referral Services. DRS, which procured body parts from corpses in funeral homes, is at the center of the nationwide recall.
The tissue-transplant industry is made up of nonprofit and for- profit entities that gather tissue from cadavers to be used in medical operations such as reconstructive knee surgeries or spinal operations.
Federal regulators recently shut down DRS after an investigation raised questions about deficiencies in the company’s manufacturing and record-keeping practices, said Paul Richards, a spokesman for the Food and Drug Administration.
Richards said the FDA has initiated a broad recall of tissue collected by DRS, citing concerns that the company had collected tissue from deceased donors with diseases or a history of drug use.
He declined to say how many pieces of tissue were to be recalled.
“From a public-health perspective, it was important to move forward (with the recall) to assure adequate protection against communicable diseases,” said Richards.
The FDA could eventually ask patients who received the pieces of tissue to be screened for diseases, he said.
Of the 312 tissue pieces distributed by U.S. Tissue and Cell, 20 to 30 pieces were used in medical procedures, said Cycyota. The tissue pieces went to surgery centers or hospitals in Cincinnati and elsewhere in the U.S.
Cycyota said none of the tissue distributed by U.S. Tissue & Cell that is to be recalled went to AlloSource customers or facilities in Denver.
Because AlloSource acquired the distribution records and most of U.S. Tissue & Cell’s assets, AlloSource was the best entity to handle the recall, he said.
Cycyota said AlloSource “will spend into the six figures” on the recall, which includes contacting patients and tracking down all tissue pieces.
AlloSource reported $38.7 million in revenue during its 2004 fiscal year, according to public records.
The investigation of DRS follows a 2005 scandal involving the tissue-transplant industry.
New Jersey-based Biomedical Tissue Services was accused last year by authorities of procuring potentially tainted tissue from stolen bodies.
The risk to patients of such tissue – although slight – is infections such as hepatitis, AIDS or other diseases.
“A recall doesn’t mean recipients are at risk,” said Dr. Michael Bauer, medical director at Denver’s Bonfils Blood Center and a consultant to the tissue-transplant industry. “What’s clear is that when there’s a breach of FDA guidelines, it necessitates a recall.”
Staff writer Will Shanley can be reached at 303-820-1260 or wshanley@denverpost.com.
