Interesting timeline and comments :)
Apr-2010 Beckman remove AccuTnI kits due to not obtaining appropriate product clearances. "FDA has indicated to us that it believes certain modifications to our troponin test kits, as used on our DxI systems as well as used on our Access systems, were made without obtaining appropriate product clearances from the agency."
Jul-2010 Southern Cross analysis report - "Mix&Go can improve the performance of ‘difficult’ tests. Some currently marketed diagnostics are widely acknowledged to have lower than desirable sensitivity but are used anyway for want of anything better. A good example until recently was tests for a protein complex called troponin, used in persons who have chest pain to see if they have had a heart attack. Mix&Go has potential to boost the sensitivity of these kinds of difficult tests."
Jun-2011 Danaher acquire Neckman Coulter for $6.8B
Sep-2012 Article http://www.miamiherald.com/2012/09/30/3027476/beckman-coulter-remains-a-major.html "...submitted approval for AccuTni..." but when ?
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