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U.S. News

Blood Tests for Hepatitis B Recalled

January 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.

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For more information, visit www.fda.gov/medwatch/safety/2006/safety06.htm#vitros.

Back to other news for January 11, 2006

Adapted from:
Reuters
01.10.06


  
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This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
 
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