Company: Sysmex Corp
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 for review of source codes in design controls for software validation, and there is no assurance that all lines and possibilities in the source codes are executed at least once.
FDA District: Center for Devices and Radiological Health (CDRH)