CLINITEK, product family

Manufacturer

Siemens Healthcare Diagnostics Inc.(6)

Basic UDI-DI

0405686901945WD

Risk class

Class A·Class I (varies)

Legislation

IVDR

EMDN category

AUTOMATED URINE ANALYSERS

Market status

6 on the market

Official record

EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 0405686901945WD.

• Z-0083-2015 ·Class II · terminated · 19 Sep 2014
  The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
• Z-0081-2015 ·Class II · terminated · 19 Sep 2014
  The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
• Z-0082-2015 ·Class II · terminated · 19 Sep 2014
  The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
• Z-1545-2014 ·Class III · terminated · 26 Feb 2013
  Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

Recalls matched to the 6 devices listed on this page; other pages of the family can carry others.