FDA: Abbott failed to reveal facts about Prism

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The FDA says product information sheets, a launch presentation and a customer letter for Abbott’s Prism HBsAg (antibody to hepatitis B surface antigen [mouse monoclonal IgM]) and Prism HBcore (hepatitis B virus core antigen [E. coli, [recombinant]) were false and misleading because they failed to reveal facts on important risks associated with the products.

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