Alere INRatio2 PT/INR Professional Test Strips Recalled (Class I) due to Higher INR when Performed by Central Laboratory
Cardiology, Emergency medicine, Laboratory and Nursing personnel are informed by the FDA that Alere INRatio2 PT/INR Professional Test Strip is recalled due to higher INR when performed by a central laboratory.
FDA Alert on Alere INRatio2 PT/INR Professional Test Strip
FDA’s reason for the recall is that there were complaints of patients (three of which described bleeding associated with patient deaths) who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip (PN 99008G2) but a significantly higher INR when performed by a central laboratory. The specific strips may report an inaccurately low INR result.
Current Alere INRatio2 PT/INR Professional Test Strip customers will be switched to the Alere INRatio PT/INR Test Strip (PN 100139). Alere INRatio PT/INR Test Strip (PN 100071), for self-testing, is not affected by this recall.
The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.
FDA Recommendation on Alere INRatio2 PT/INR Professional Test Strip
“Healthcare professionals should immediately STOP using the Alere INRatio2 PT/INR Professional Test Strips and use an alternative method 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.”
Contacting the FDA to report cases with Alere INRatio2 PT/INR Professional Test Strip
In case of detection of adverse events or side effects related to the use of Alere INRatio2 PT/INR Professional Test Strip, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:
- The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
- The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
- The completed form can be faxed to: 1-800-FDA-0178
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