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Roche recalls CoaguChek monitors

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Roche recalls CoaguChek monitors

Roche Diagnostics Australia, has announced a recall of its CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro INR monitors, for a “product correction”, after consultation with the TGA.

CoaguChek INR monitors are used by health professionals and for self-testing by patients taking anticoagulant medicines, sometimes referred to as 'blood-thinners', such as warfarin.

A single case has been identified, in which a patient being treated with antibiotics and chemotherapeutics, in addition to their anticoagulant medicine, received an 'ERROR 6' message rather than the INR value while using a CoaguChek INR monitor. If this issue occurs, there is a risk that a patient's INR value could be extremely high and require medical attention without them knowing it.

An 'ERROR 6' message normally indicates test strip interference, such as the test strip being touched or removed during testing. However, in the above situation, the INR monitor was unable to differentiate the medicine interaction from the test strip interference.

The affected material numbers are:

  • 04796179001
  • 04811500001
  • 04963733001
  • 06505597001
  • 04800842190
  • 05864640001
  • 06505589001
  • 06644511001
  • 05530199190

Roche Diagnostics Australia has contacted all patients with affected devices to notify them of this issue. Roche Diagnostics Australia will also be including updated information regarding 'ERROR 6' and revised recommendations of what to do if it occurs in the device's Instructions for Use and the package insert for CoaguChek XS PT strips, which are used in each of the affected models.



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