A New Jersey biomedical supply house that illegally removed body parts for sale failed to test the blood of some donors, federal regulators said Thursday.
The Food and Drug Administration reiterated its recommendation that patients who received transplanted tissues collected by the company should be tested for HIV, hepatitis and syphilis.
Biomedical Tissue Services, of Fort Lee, N.J., submitted blood samples for required testing that in some cases did not come from the donor from whom tissues were then harvested for transplant, the Food and Drug Administration said.
As a result, the test results may not reflect whether the actual tissue donor was free of disease, the FDA said in a public health notification.
The owner of the company and three others were charged last month in what prosecutors said was a multimillion-dollar scheme to sell body parts for use in transplants.
Prosecutors said they obtained bodies from funeral parlors in three states and forged death certificates and organ donor consent forms to make it look as if the bones, skin, tendons, heart valves and other tissues were legally removed.
Prosecutors said the defendants took organs and other tissues from people who had not given consent or were too old or too sick to donate. The defendants forged consent forms and altered the death certificates to indicate the victims had been younger and healthier, officials said.
The FDA has said recipients of donated tissues harvested by the company face a potential, but low, risk of infection.
