www.fdanews.com/articles/146492-faulty-reading-pushes-devicemaker-to-issue-field-safety-notice
Faulty Reading Pushes Devicemaker to Issue Field Safety Notice
May 17, 2012
BBI Healthcare has issued a field safety notice for its Clever Chek blood glucose monitoring system. The meter does not alert users when insufficient blood has been applied, creating the potential for falsely low blood glucose results if the test strips are under-filled, and falsely high results if over-filled.