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U.S. Department of Health and Human Services

Safety

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Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit

Audience: Clinical laboratory personnel

[Posted 01/09/2006] Ortho-Clinical Diagnostics and FDA notified healthcare professionals and clincal laboratory staff of a class 1 recall of the HBsAg Confirmatory Kit due to an unknown component in the diluting solution used to test blood and serum samples that may produce 'Not Confirmed' results for samples found to be positive with the initial test. This can cause some results to be classified as false negatives. False negative results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially true for pregnant women whose tests show false negative results. The company recommends that previously reported results be reviewed.

[January 09, 2005 - Recall Notice - FDA]