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FDA Warns Beckman Coulter On Marketing Of "AccuTnI" Heart Test

By Jennifer Corbett Dooren and Jon Kamp Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration said a Beckman Coulter Inc. (BEC) heart test was illegally being marketed without agency clearance. In a June 21 warning letter sent to the company, the FDA said the firm's "AccuTnI on the Access Immunoassay System" is considered a medical device intended for use in the diagnosis of disease. The warning letter was posted to FDA's website Tuesday. The product is designed to test for a protein called troponin I, which is considered a marker for heart problems. In April, the company had said it would remove the AccuTnI Troponin kits from its UniCel Dxl immunoassay system after the FDA had said the tests required agency approval. It's not immediately clear if the UniCel system is different from the access immunoassay system referenced in the FDA letter. Neither the FDA nor the company immediately returned requests for comment. -By Jennifer Corbett Dooren and Jon Kamp, Dow Jones Newswires; 202-862-9294; [email protected]

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