Roche Recalls Potentially Faulty Heart Attack Test Tools

Law360, Chicago (April 24, 2012, 6:27 PM EDT) -- Roche Diagnostics Operations Inc. is recalling two lots of its Elecsys Troponin I heart attack diagnosis tools because they may yield inaccurate results that could be life-threatening, the U.S. Food and Drug Administration said Tuesday.

In a notice on its website, the FDA said Roche was recalling lot numbers 163176 and 163177 of its Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays that were distributed from June 29 through Jan. 13.

The recall is categorized as Class 1, the most serious type of recall that...
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