FDAnews Device Daily Bulletin

ORTHO-CLINICAL DIAGNOSTICS ISSUES VOLUNTARY RECALL FOR SIGNAL REAGENT

April 20, 2006
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Ortho-Clinical Diagnostics has issued a voluntary Class I recall for its VITROS Immunodiagnostic Products Signal Reagent. The recall was initiated March 28 for the product, which is 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 and C, thyroid disorders, HIV and pregnancy.

The recall was issued because a decreased signal in the reagent may in some cases produce inaccurate results affecting the outcome of the diagnostic tests, the agency said.

To access the recall, visit http://www.fda.gov/cdrh/recalls/recall-032806.html (http://www.fda.gov/cdrh/recalls/recall-032806.html).