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U.S. Department of Health and Human Services

Safety

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Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products Troponin I Reagent Pack

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

[UPDATE 05/22/2007] Recall classified by FDA as Class I.

[Posted 05/07/2007] Ortho-Clinical Diagnostics and FDA notified healthcare professionals of a nationwide recall of the Vitros Immunodiagnostic Products Troponin I Reagent Pack, Lots 3151 and 3170. The product was recalled after a small number of clinical laboratories administering the test reported shifts in quality control results causing the potential for false negative troponin I results at very low levels. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when it fact they had.

A troponin I test is usually ordered with other cardiac tests in the hospital to determine if a patient has had a heart attack or injury to the heart muscle. The identified product lots were distributed to clinical laboratories within and outside the United States between January and March of 2007. Clinical laboratories in possession of the identified lots are instructed to discontinue use of the product and notify healthcare professionals who ordered the test in recent weeks.

[May 22, 2007 - Recall Notice - FDA]
[May 04, 2007 - Press Release - Ortho-Clinical Diagnostics]