Alere Inc. located in Waltham, Massachusetts, just issued an urgent recall of its PN 99008G2 INRatio2 PT/INR Professional Test Strips. The U.S. Food and Drug Administration has designated this recall a Class I, its most serious designation and involving a situation in which there is a reasonable probability that the use of, or exposure to, the recalled product will cause serious adverse health consequences or death.
To date, Alere indicated that it has received nine serious adverse event reports, three have been described as bleeding associated with patient deaths. The adverse event reports involved significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma International Normalized Ratio (INR) test. The Alere INRatio2 PT/INR Professional Test Strip results were between 3.1 and 12.2 INR units lower than the laboratory result.
The recalled test strips are used by healthcare professionals with Alere’s INRatio2 PT/INR Monitor to test how long it takes for blood to clot in patients taking the blood thinner, warfarin. “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,” Alere Inc. indicated in a press release, according to QMed.
Alere initiated the recall after receiving patient complaints from individuals who received a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but, following testing by a central laboratory, received a significantly higher INR result that was outside of the therapeutic range, wrote QMed. Alere indicated that it was concerned that the involved Alere INRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result.
Alere indicated that customers currently using the INRatio2 PT/INR Professional Test Strips will be transitioned to the INRatio PT/INR Test Strip (PN 100139) and that this recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring, QMed reported.
The FDA posted a Safety Information advisory regarding the recall and advises healthcare professionals to immediately stop using the Alere INRatio2 PT/INR Professional Test Strips. The FDA also indicates that patients and health care providers utilize an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, a different Alere product, or a different point-of-care monitoring system from a different manufacturer. Alere noted that it is investigating the matter and that customers should return unused product to the company.
Because the root cause for the problem has not been determined, Alere is unable to determine the patient conditions or circumstances that may contribute to the discrepancy. Alere may be reached at 1.844.292.5373 or online at www.inr-care.com.
The Alere INRatio2 PT/INR Professional Monitoring System consists of the Alere INRatio2 PT/INR Monitor and the Alere INRatio2 PT/INR Professional Test Strip and is intended for use in the quantitative determination of INR in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio2 PT/INR Professional Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio2 PT/INR Professional Monitoring System is not intended to be used for screening purposes or in patients transitioning from heparin treatment to warfarin therapy.