Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
The blood chemistry analyzers INNOVASTAR and RESPONS 910/920 and BIOMAJESTY from DIASYS® laboratory equipment with an automated platform, continuous random access controlled by their software, colorimetric techniques, ISE, nephelometry and enzymatic porinmunoassays for multiple tests for endocrinology, chemistry and immunology , both quantitative and qualitative. Processes urine, fluid, serum or plasma samples for in-vitro diagnostic tests (IVD). The reagents used with the analyzers for INNOVASTAR and RESPONS 910/920 and BIOMAJESTY of DIASYS have respective health records.