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U.S. News Blood Tests for Hepatitis B RecalledJanuary 11, 2006 On Monday, Johnson & Johnson and U.S. regulators said 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, spokesperson for the Johnson & Johnson's Ortho-Clinical Diagnostics unit. 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. Reuters 01.10.06  This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.
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