Regulatory

J&J recalls some hepatitis blood tests

Last Updated: 2006-01-10 10:00:53 -0400 (Reuters Health)

WASHINGTON (Reuters) - Johnson & Johnson has recalled some blood tests that may give false negative results when used to confirm infection with the hepatitis B virus, the company and U.S. regulators said on Monday.

The manufacturer is not aware of any cases in which an incorrect result was given to a patient, said Mary Richardson, a spokeswoman for Johnson & Johnson unit Ortho-Clinical Diagnostics.

But she said a problem had been uncovered with three lots of the test, the Vitros Immunodiagnostic HBsAG Confirmatory Kit. An unknown component in the diluting solution may produce an incorrect negative result for samples that initially test positive for hepatitis B, a disease that destroys the liver.

The company has replaced the affected products, which were distributed in the United States and Europe, Richardson said.

In a notice posted on the Food and Drug Administration Web site http://www.fda.gov/medwatch/safety/2006/safety06.htm#vitros, Ortho-Clinical urged medical facilities, laboratories and public health agencies that had received the tests to review previous results.