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Alere INRatio2 PT/INR Professional Test Strips: UPDATE - Significant Discrepancy in INR Results May Lead To a Delay In An Urgent Medical Decision
UPDATE 12/09/2014. Alere Inc. initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labelling for performing the test are not followed.
The INRatio and INRatio2 PT/INR Monitor system should not be used on patients with any of the following conditions:
- Anemia of any type with hematocrit less than 30%
- Any conditions associated with elevated fibrinogen levels including:
- Acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
- Chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
- Severe infection (e.g., sepsis)
- Chronically elevated fibrinogen for any reason
- Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis
- Any bleeding or unusual bruising, clinically observed or reported by the patient
Patients with any of the conditions listed above should immediately be transitioned to a laboratory INR method for monitoring their INR and warfarin therapy.
Read the UPDATED MedWatch safety alert, including links to the press release and FDA recall notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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