Corrective Action for EasyLink Informatics System, Siemens Healthcare
2009.08.13
Product group In-vitro diagnostics
Reference 02617/09
Corrective Action of Siemens Healthcare Diagnostics for EasyLink Informatics System because of the possibility of falsely high results by manually diluting without unique sample ID. The customers were informed about the problem and how to avoid it. (EasyLink Informatics System is not a CE-certified medical device but it is connected to IVD’s).