Alere Issues Urgent Recall of Warfarin INR Test Strips

Concerned over nine serious adverse events, three of which described bleeding associated with patient deaths, Alere Inc. of Waltham, MA issued a voluntary urgent recall of its PN 99008G2 INRatio2 PT/INR Professional Test Strips. The recall later received Class I status from FDA.

The test strips are used with Alere's INRatio2 PT/INR Monitor by healthcare professionals to test patients taking the blood thinner warfarin. They measure how long it takes blood to clot. "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," the company said in a press release.

Alere says it initiated the voluntary recall after receiving complaints from patients who had a therapeutic or near-therapeutic International Normalized Ratio (INR) with the Alere INRatio2 PT/INR Professional Test Strip but, when testing was performed by a central laboratory, a significantly higher INR result (outside of therapeutic range) was returned. Given these reports, the company is concerned that the Alere INRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result.

According to the company, customers who are currently using the INRatio2 PT/INR Professional Test Strips will be transitioned to the INRatio PT/INR Test Strip (PN 100139).

The recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.

FDA has posted a Safety Information advisory regarding the recall. It advises healthcare professionals to immediately stop using the Alere INRatio2 PT/INR Professional Test Strips. FDA says an alternative method should be used to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer.

Alere says it is conducting a thorough investigation into these events and has requested that customers return unused product to the company. Adverse events or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Stephen Levy is a contributor to Qmed and MPMN.