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U.S. Department of Health and Human Services

Safety

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CARDIAC Reader System

Audience: Clinical laboratory specialists and healthcare professionals

Roche Diagnostics announced a recall for the CARDIAC Reader system due to the potential for falsely decreased or false negative Troponin T results and falsely decreased Myoglobin results. These tests are used as part of the diagnostic process for myocardial infarction (heart attack).

[December 8, 2004 - Recall Notice - FDA]