INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR ResultsAUDIENCE: Cardiology, Laboratory, Gastroenterology, Infectious Disease, Nursing, Pharmacy ISSUE: Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. BACKGROUND: In December 2014, Alere initiated a voluntary correction to inform users of the INRatio and INRatio2 PT/INR Monitoring System that patients with certain medical conditions should not be tested with the system. As part of its commitment to ensuring the safety of patients, Alere proactively reported these device concerns to the FDA and began conducting a thorough investigation into these events. Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method. Although Alere is confident that the software enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market. RECOMMENDATION: Alere is committed to ensuring an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. We suggest that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices. 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:
Read the MedWatch safety alert, including links to the Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm510889.htm You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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