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U.S. Department of Health and Human Services

Safety

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Ortho Antibody to HBsAg ELISA Test System 3

Audience: Blood bank and other laboratory professionals

Ortho-Clinical Diagnostics Inc. and FDA notified healthcare professionals of reports of increased initial reactive (IR) and repeat reactive (RR) rates obtained with the Antibody to HBsAg ELISA Test System 3 donor screening assay, with false repeat reactive results being confirmed using the Antibody to HBsAg ELISA Test System 3 Confirmatory Test. Ortho is currently examining available information as to the causes of these events. The letter recommended measures to mitigate problems with the donor screening assay, and provided changes made to the instructions for use of the Antibody to HBsAg ELISA Test System 3 Confirmatory Test kit.

[December 23, 2003 - Letter - Ortho-Clinical Diagnostics Inc.]