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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; jennifer.corbett@dowjones.com

Stock News for Beckman Coulter (BEC)
DateTimeHeadline
06/28/201113:48:41CORRECT:Danaher In Market With Offering To Help Fund Acquisition
06/17/201104:07:36EU Clears US Technology Firm Danaher To Buy Beckman Coulter
04/18/201111:54:16Beckman Coulter Delays FDA Filings For Key Heart Test To 3Q
02/25/201112:38:49PerkinElmer Isn't For Sale, CEO Says; Shares Slide
02/24/201111:44:18PerkinElmer, After Beckman-Bid Loss, Is Mulling Deals -Bloomberg
02/07/201116:48:21Beckman Deal Moves Danaher Deeper Into Technology Sector
02/07/201108:14:50Danaher Agrees To Acquire Beckman Coulter For $5.87 Billion
01/28/201114:25:16KKR Said To Drop Out Of Beckman Coulter Bid Group -Bloomberg
07/06/201015:19:05FDA Warns Beckman Coulter On Marketing Of "AccuTnI" Heart Test
05/14/201009:52:56Beckman Coulter Expects First Half 2011 Troponin Filing
12/17/200917:11:22Beckman Coulter Targets Mid-Teens Earnings Growth In 2010

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