Alere announced a voluntary Class 1 recall of the Alere INRatio2 PT/INR Professional Test Strips due to significantly different test results between the Alere INRatio2 PT/INR Professional Test Strips and the local laboratory plasma INR test.
Patient complaints showed those who had a therapeutic or near therapeutic INR result with the Alere INRatio2 PT/INR Professional Test Strip (PN 99008G2) actually had a much higher INR when performed by a central laboratory.
A total of 9 serious adverse event reports have been filed, 3 of which showed bleeding associated with patient deaths. Due to the possible inaccurate low INR results, Alere has advised customers to immediately stop using the Alere INRatio2 PT/INR Professional Test Strips. Alternate methods of PT/INR testing, such as plasma-based laboratory INR test, or the use of an alternate Alere product or point-of-care monitoring system is recommended.
Alere has requested that customers return unused product to the company. Customers will be transitioned from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). This recall does not affect the strips used by self-testers at home for INR monitoring (PN 100071).
Alere is conducting a thorough investigation into the cause for these events.
For more information call (844) 292-5373 or visit INR-Care.com.