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U.S. Department of Health and Human Services

Safety

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Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Signal Reagent

Audience: Diagnostic laboratory managers and hospital risk managers

[Posted 04/18/2006] Ortho-Clinical Diagnostics and FDA notified healthcare professionals of a Class 1 recall of this reagent, a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B or C), thyroid disorders, HIV and pregnancy. A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests.

Customers with the affected lot numbers should discontinue using any remaining reagent and should follow the enhanced Quality Control (QC) procedure provided by Ortho-Clinical Diagnostic for each pack in all lots of VITROS Signal Reagent until further notice. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results should discuss them with their physicians - cardiac disease, hepatitis (A,B, or C), thyroid disorders, HIV and pregnancy.

[April 18, 2006 - Class 1 Recall - FDA]