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Johnson & Johnson and U.S. regulators announced that the company has recalled some blood tests for hepatitis B virus because they may give false negative results. The affected products, which were distributed in the United States and Europe, have been replaced, said Mary Richardson, spokeswoman for the Johnson & Johnson's Ortho-Clinical Diagnostics division.
The problem has been discovered in three lots of the Vitros Immunodiagnostic HBsAg Confirmatory Kit, Richardson said. An unknown component in the diluting solution may produce a false negative result for samples that initially tested positive.
Johnson & Johnson is not aware of any cases in which an incorrect result was given to a patient, said Richardson. The company is asking health care facilities and agencies that received the recalled tests to review previous results.
Hepatitis B virus can be transmitted through sexual contact, and gay and bisexual men are urged by health organizations to be vaccinated against both hepatitis A and B. No vaccine currently exists to prevent hepatitis C infections. The Gay and Lesbian Medical Association says that despite the availability of the hepatitis A and B vaccines, fewer than half of sexually active gay men have been vaccinated against the diseases. (Reuters, with additional reporting by Advocate.com)
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