May 6, 2014 — Alere has issued an urgent Class I recall (PDF) for blood clot test strips. They may give inaccurate readings that can lead clinicians to administer an improper dose of the blood-thinner warfarin, resulting in bleeding or other side effects. At least nine serious adverse events have been reported, including three deaths.
The test strip is used by healthcare professionals to determine the patient’s International Normalized Ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time.
Recalled products include:
- Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2).
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.
Alere said that the adverse events were due to “significantly different” test results between the strip and the local laboratory plasma test. The Alere INRatio2 PT/INR Professional Test Strip results were between 3.1 – 12.2 INR units lower than the laboratory result.
They have not yet determined the root cause of the problem. In the meantime, Alere advises customers to immediately stop using the recalled test strips and use an alternative method to perform PT/INR testing, such as a plasma-based INR test.
Customers with questions regarding this recall or requiring replacement product can contact Alere at 844-292-5373.