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Hepatitis B test kit recalled.

Ortho-Clinical Diagnostics Inc. and the Food and Drug Administration have issued a class I recall of the VITROS immunodiagnostic HBsAg confirmatory kit because of false-negative results in the confirmation of the presence of hepatitis B surface antigen in human blood and plasma.

An unknown component in the diluting solution that is used to test blood and serum samples may produce "not confirmed" results for samples that are found to be positive with the initial test, resulting in false negatives.

False-negative results may prevent some patients who are infected with or carrying the virus from receiving necessary treatment. The possibility of false-negative results is of particular concern for pregnant women. "When their fetuses are born, they will be presumed negative, and [will not be] treated with the hepatitis B immunoglobulin and hepatitis B vaccine. Such infants have a 90% chance of progressing to chronic hepatitis B virus infection, resulting in possible liver transplantation or early death," according to the FDA.

In mid-December, the company sent letters to medical facilities, testing laboratories, and public health agencies instructing customers to discontinue use of the kits and discard any remaining inventory. Previously reported results should be reviewed. Those with questions should contact Ortho-Clinical Diagnostics' Judy M. Strzepek by calling 908-218-8524.

A class I recall is the most serious type of FDA recall. It involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.
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Title Annotation:Ortho-Clinical Diagnostics Inc recalls
Author:Splete, Heidi; Wachter, Kerri
Publication:Internal Medicine News
Article Type:Brief article
Geographic Code:1USA
Date:Mar 15, 2006
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