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# Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory
- URL: https://www.foodconsumer.org/alere_inratio2_pt_inr_professional_test_strips_0507141140/
- Published: 2014-05-07T12:39:00.000Z
- Updated: 2026-09-22T16:31:27.000Z
- Description: Alere is recalling its INRatio2 PT/INR Professional Test Strips after reports that patients with therapeutic readings on the strips had significantly higher INR values in central laboratory tests. Nine serious adverse events were reported, three describing bleeding with patient deaths.
- Author: Food Consumer
- Tags: Miscellaneous, Health News, #vivvo-import

# **AUDIENCE**: Cardiology, Emergency Medicine, Laboratory, Nursing

**ISSUE**: Alere is recalling this product due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths.

**BACKGROUND**: The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. Given these reports, Alere is concerned that the AlereINRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result. 

Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.

**RECOMMENDATION**: 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. 

 Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

- Complete and submit the report Online: [www.fda.gov/MedWatch/report.htm](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTA3LjMxOTYxNDgxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUwNy4zMTk2MTQ4MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODI2ODM5JmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)
- [Download form](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTA3LjMxOTYxNDgxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUwNy4zMTk2MTQ4MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODI2ODM5JmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&101&&&http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149236.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) or call [1-800-332-1088](tel:1-800-332-1088) to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

[http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm396324.htm](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTA3LjMxOTYxNDgxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUwNy4zMTk2MTQ4MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODI2ODM5JmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&102&&&http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm396324.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

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