Company: Sysmex CorpDate: 01/22/2002 Product name: Clinical laboratory diagnostic devices, including hematology, reticulocyte, urinalysis and coagulation analyzers Failure to establish and maintain documented procedures to control and verify the design of the device in order to ensure that specified design requirements are met, as specified in 21 CFR 820(a)(1). For example, there were no procedures...Read More