December 9th, 2014

FDA Announces Voluntary Urgent Correction for INR Testing

FDA Announces Voluntary Urgent Correction for INR Testing

December 9, 2014

The U.S. Food and Drug Administration (FDA) announced on Monday that Alere has launched an urgent voluntary correction of its INR testing monitor.

The purpose of the correction is to inform customers in the United States that the Alere INRatio and INRation 2 PT/INR monitoring system should not be used for patients with certain medical conditions as use could result in a clinically significant lower result.

The FDA’s statement listed the following medical conditions:

• Anemia of any type with hematocrit less than 30%
• Any conditions associated with elevated fibrinogen levels including:
• Acute inflammatory conditions (such as acute viral or bacterial infections such as pneumonia or influenza)
• Chronic inflammatory conditions (such as 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.

Alere recommends the following actions:

• Patients with these conditions should switch to a laboratory INR method for warfarin monitoring.
• Healthcare professionals and self-testing patients should make sure that they periodically undergo the laboratory INR method.
• Patients with a significant discrepant low result should transition to another method for warfarin INR monitoring.
• Patients should be tested to ensure that their hematocrit falls between 30% and 55%.

The company is working to improve its INR meters to eliminate the discrepant results.

If you have questions you can contact Alere at 1-877-929-2579.

Reference:

1. Alere initiates voluntary URGENT CORRECTION for use of Alere INRatio and INRatio 2 PT/INR Monitor System. www.fda.gov. 2014 Dec 8.