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U.S. Department of Health and Human Services

Safety

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Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack

Audience: Clinical laboratory specialists, risk managers

FDA and Ortho-Clinical Diagnostics notified healthcare professionals of a Class I recall of four lots of the VITROS Troponin I Reagent Pack, a laboratory test used by professionals to measure the quantity of cardiac troponin I in human blood to aid in the diagnosis of heart attack. The recall was initiated due to random occurrences of false positive test results which could lead to unnecessary medical procedures. Clinical laboratories were instructed by the firm to stop using the product, discard any remaining material and notify the health care provider who ordered the test. FDA considers that the probability of life threatening consequences is likely to occur by use of these products.

[July 19, 2004 - Recall Notice - FDA]