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.
For more information, visit www.fda.gov/medwatch/safety/2006/safety06.htm#vitros.
Single-Day, Patient-Initiated Famciclovir Therapy for Recurrent Genital Herpes: A Randomized, Double-Blind, Placebo-Controlled Trial
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.