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Instruments, reagents, controls and calibration
Our main aims in business are to make sure we provide excellent products and service, that we contribute positively to healthcare around the world and that our customers are fully satisfied. Of course, these aims apply especially to our in-vitro diagnostic testing. It’s fair to say, this focus on excellence is one of the contributing factors for our success.
A prerequisite for reliable and correct results – for which we take full responsibility – is that our users use the ‘Sysmex System’. This means using not only Sysmex instruments, but also our reagents, controls and calibrators. Each of these is aligned to the other and interacts and complements perfectly, forming a system. We and our partners can only take full responsibility for the reliability of the results and provide you with our excellent service when you make use of the complete Sysmex System.
There are several non-Sysmex reagents on the market. Manufacturers claim that they are compatible with our analysers, and they use names similar to ours. Clearly these are not approved by us. We have to point out that by using such third-party products, you are actively changing the stated ‘intended use’ of our system – Sysmex analyser, Sysmex reagents, Sysmex controls, and Sysmex calibrators. As a result, you legally become the ‘responsible manufacturer’ with all IVD-CE mark duties in Europe for this ‘new combination’ of Sysmex products with non-Sysmex products. Please understand that we cannot assume any liability for our systems’ performance in such cases.
Don’t take risks…