News | Blood Testing | July 12, 2016

Alere Initiating Voluntary Recall of INRatio and INRatio2 PT/INR Monitor System

Company enacts recall over FDA concerns about software updates to improve measurement results

Alere, INRatio PT/INR Monitor, voluntary recall, FDA

July 12, 2016 — Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio 2 PT/INR Monitoring System. Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.

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.

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.

In light of this input from the FDA and the company’s business considerations, Alere has recently determined to voluntarily remove the INRatio system from the market. The company will provide further information on patient transition to patients and healthcare providers. It suggests that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.

For more information: www.inr-care.com


Related Content

Technology | Blood Testing

October 9, 2019 — Abbott recently announced that its Architect Stat High Sensitivity Troponin-I blood test has received ...

Home October 09, 2019
Home
News | Blood Testing

September 18, 2019 — Discharge of patients with suspected acute coronary syndromes under a 0- and 1-hour high ...

Home September 18, 2019
Home
News | Blood Testing

March 19, 2019 — Prevencio Inc. announced data confirming the high accuracy of its artificial intelligence (AI)-driven ...

Home March 19, 2019
Home
News | Blood Testing

December 28, 2018 —Terrific Care LLC. / Medex Supply Dist Inc. initiated a nationwide recall on Dec. 19 of Roche ...

Home December 28, 2018
Home
News | Blood Testing

October 26, 2018 — For someone experiencing cardiac symptoms in the emergency room, every minute matters as physicians ...

Home October 26, 2018
Home
News | Blood Testing

October 24, 2018 — For those living with diabetes, monitoring blood glucose accurately is necessary to prevent diabetes ...

Home October 24, 2018
Home
News | Blood Testing

October 16, 2018 — Abbott announced that its High Sensitive Troponin-I blood test has received CE Mark for distribution ...

Home October 16, 2018
Home
News | Blood Testing

September 4, 2018 — Prevencio Inc. announced new data demonstrating its HART PAD test accurately diagnoses peripheral ...

Home September 04, 2018
Home
News | Blood Testing

August 6, 2018 — A new test to assess a whether or not someone is having a heart attack upon arriving in the emergency ...

Home August 06, 2018
Home
News | Blood Testing

March 26, 2018 — Measurement of cardiac troponin in stable patients with chest pain using the ultra-sensitive Singulex ...

Home March 26, 2018
Home
Subscribe Now