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U.S. Department of Health and Human Services

Safety

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Abbott Laboratories Architect Stat Troponin-1 Immunoassay

Audience: Hospital Risk Managers, hospital administrators, clinical laboratories, healthcare professionals

[Posted 06/08/2007] Abbott Laboratories and FDA notified healthcare professionals of a Class I Recall of the Architect Stat Troponin-1 Immunoassay. Doctors use this test in diagnosing damage to the heart and/or a heart attack in people who have had chest pain. The product was recalled after a small number of clinical laboratories reported inconsistent or invalid test results at very low levels of troponin-1 (i.e., less than 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may impact patient treatment. Laboratories are advised to be cautious when reporting results at or near the lower limit of detection and to advise physicians ordering the tests about the possibility of inaccurate results at those levels.

[June 08, 2007 - Recall Notice - FDA]