May 6, 2014 — Alere has published an Urgent Product Recall (PDF) for blood clot test strips because they may produce inaccurate results. Nine incidents have been reported, including three cases in which serious bleeding resulted in death.
The recall affects Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2), which are used to measure International Normalized Ratio (INR) in fresh capillary whole blood. Healthcare professionals use the test strips to monitor the effect of warfarin, a powerful blood-thinner, on clotting time.
Alere has found that the test strips produce “significantly different” test results than the local laboratory plasma test — results were between 3.1 – 12.2 INR units lower than the laboratory result.
The inaccurate test results may cause healthcare professionals to administer an inappropriate dose of warfarin, which could lead to a life-threatening bleeding event. According to Alere:
“The root cause for this issue has not yet been determined; therefore Alere cannot determine the patient conditions or circumstances that may contribute to the discrepancy.”
In the meantime, healthcare professionals should stop using Alere blood clot test strips, and instead use an alternative method to perform PT/INR testing. The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.