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False Negative Results with VITROS Troponin I Reagent Pack

Posted on April 29, 2008

Ortho-Clinical Diagnostics has notified healthcare professionals about a recall of the company's VITROS Troponin I Reagent Pack because of the potential for false negative results when troponin levels are only slightly elevated. A false negative might indicate that a patient had not experienced a heart attack when in fact an MI had actually taken place.

The affected lot numbers are 3151 and 3170. Clinical labs who have these lots have been instructed to stop using the product, and notify physicians who have ordered the test in recent weeks. Labs with questions on this recall can contact the company at 1-800-421-3311.

Additional Information:

FDA MedWatch Safety Alert. Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Troponin I Reagent Pack. May 7, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Vitros

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