Recall of Vitros Confirmatory Test for Hepatitis B (Mar. 06)

Ortho Clinical Diagnostics has recalled certain lots of the company's Vitros HBsAg Confirmatory Kit. This kit is used to confirm the presence of the antigen after a positive test with the Vitros HBsAg Reagent pack. Because of a problem with a diluting solution, the Confirmatory Kit may indicate "not confirmed" for some samples. 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 because a pregnant woman might be tested only for hepatitis B surface antigen and not for the core IgM antibodies. A "not confirmed" test result could lead to her newborn infant not being treated appropriately at birth, and this can have grave consequences. Without treatment, the infant is likely to progress to a chronic hepatitis B infection, and this can eventually lead to severe liver damage, the need for a liver transplant, or early death.

Ortho-Clinical sent letters via overnight mail to medical facilities, testing labs and public health agencies on 12/15/2005, instructing customers to discontinue use and discard remaining inventory. In a separate Q&A sheet, the company recommends that users go back and review the results that were previously reported by these confirmatory kits. Contact the company for this information, as well as the affected lot numbers.

Additional Information:

FDA MedWatch Safety Alert - Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit. January 9, 2006.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#vitros

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• Vitros
• Confirmatory
• Test
• Hepatitis
• Recall
• FDA
• False
• Negative