FDA MedWatch – INRatio and INRatio2 PT/INR Monitor System by Alere

KCER Release Date: July 13, 2016

Audience: ESRD Networks and Facilities, Nephrologists, Dialysis Staff

http://www.kcercoalition.com/en/alerts-recalls/

INRatio and INRatio2 PT/INR Monitor System by Alere: Recall – Potentially Inaccurate INR Results

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • 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

Read the MedWatch safety alert, including links to the Press Release, at:  www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm510889.htm