Alere Inc., has initiated a Class 1 recall in the US of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2).
The strips are used by healthcare professionals to determine the international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time.
Alere has received reports of patients who had a therapeutic or near therapeutic INR with the test strips but a significantly higher INR in tests performed by a central lab.
This error has been linked to 9 reports of serious adverse events, 3 of which described bleeding associated with patient deaths.
So the company has issued a recall of the Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2). This recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is used by patients for home INR monitoring.
Alere has not determined the root cause of the error but is concerned that the test strips may continue to report inaccurately low INR results. In the reports, the test strip results were between 3.1 and 12.2 INR units lower than the lab results.
Customers should stop using the Alere INRatio2 PT/INR Professional Test Strips immediately and return unused product to the company.
Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139).
Alere said it has reported this issue to the US Food and Drug Administration and is conducting a thorough investigation into the adverse events.
Customers with questions about this recall and those who require replacement product can contact Alere at 844-292-5373. For additional information on the recall, visit www.inr-care.com.
Any adverse events or quality problems related to use of the test strips can be reported to the FDA’s MedWatch Adverse Event Reporting Program.
