INR monitoring system may err in some patients

Alere is alerting clinicians who use its international normalized ratio (INR) monitoring system that results in patients with certain conditions may be clinically lower than results from a laboratory test.

Alere initiated a voluntary correction for its INRatio and INRatio2 PT/INR Monitor system, noting that in some cases results will vary from those obtained with a reference INR system. The company warned that the system should not be used in patients with:

  • Anemia of any type with hematocrit less than 30 percent
  • Any conditions associated with elevated fibrinogen levels
  • Any bleeding or unusual bruising, clinically observed or reported by the patient

Alere advised clinicians to switch patients with any of the conditions to a laboratory INR method for monitoring their INR and warfarin therapy.