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.