Chapter 2

2.14

Safety information

Notice to the user

For a patient, user, or third party in the European Union, or in countries with an identical regulatory regime
(Regulation 2017/746/EU on In Vitro Diagnostic Medical Devices), if, during the use of this device or as a result of its
use, a serious incident occurs, please report it to the manufacturer or its authorized representative in the European
Union, and to your country's relevant authority.
Reports to the authorized representative in the European Union (Sysmex Europe SE) must be sent by email to:
vigilance@sysmex-europe.com, or by post to Sysmex Europe SE, Bornbarch 1, 22848 Norderstedt, Germany.

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XF-1600 Instructions for Use