FDA Press Release - INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results
Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. Please read the full the MedWatch safety alert, including links to the Press Release, available at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm510889.htm
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
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Download form or call 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.
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