Mark A. DeSorbo

DEERFIELD, IL–At press time, an investigation continued into Baxter International Inc.'s voluntary recall of a therapy used to treat burn victims and patients in shock after tests on the remedy revealed a rare form of the AIDS virus in the plasma used to make the product.

“This is a precautionary issue, and it's a voluntary recall on just a single lot,” says Tanya Tyska, a spokeswoman for

Baxter, who declined to elaborate on the size of the recalled lot of Buminate 5%. “We're working closely with the Food and Drug Administration (FDA). We informed them of this and then issued the voluntary recall.”

Subsequent and experimental polymerase chain reaction (PCR) tests that were conducted by Baxter, she says, detected low-levels of the rare HIV-2 virus in the plasma pool used to make Buminate 5%. Reuters, however, reported although there are fewer than 100 cases of HIV-2 in the U.S., it is the main AIDS-producing virus in West Africa.

Paul Richards, a public affairs specialist for FDA's Center of Biologics Evaluation and Research (CBER), says the agency is investigating the matter, including the possibility that the PCR tests Baxter conducted, which are not federally required, delivered a false positive result.

“Due to the high sensitivity of the test, false positive reactions can occur,” Richards says.

The FDA “takes this situation seriously” and Richards also noted that to date there have not been any documented cases of contracting the AIDS virus through human albumin, the plasma protein Baxter uses to make Buminate 5%. Richards did not want to speculate on how much of the product was contained in Baxter's #29240641AA recalled lot, adding there is no federal regulation that mandates size.

During processing, Tyska says Buminate 5% is subjected to viral inactivation pasteurization, a heating process that is designed to destroy the HIV-2 virus in plasma that is extracted from donated blood.

“The manufacturing process would have killed the HIV-2 virus, and we still have a large amount of the drug in our inventory,” she says. “The product did meet FDA specifications before it was released.”

Joseph Correnti, director of research for Wayne Hummer Investments in nearby Chicago, says Baxter's voluntary recall is “a non-issue.”

“If this was tainted with anything else, it would not have made the headlines,” he says.