Alere INRatio® and INRatio®2 PT/INR

Frequently Asked Questions

published: September 15, 2016
 

1. Why is Alere withdrawing the INRatio® System from the marketplace?
  • Alere is voluntarily withdrawing the Alere INRatio® System from the marketplace, in collaboration with the FDA.
  • As always, Alere’s focus is on the safety of patients using the company’s products. Alere is deeply committed to deliver high-quality products and services that patients and providers can rely on for consistently accurate and actionable information.
  • For nearly two years, Alere has worked diligently and in consultation with the FDA to continue to support and improve anti-coagulation monitoring using the Alere INRatio® /INRatio®2 PT/INR Monitoring System. 
  • In December 2014, Alere initiated a voluntary correction to inform users of the Alere INRatio® /INRatio®2 PT/INR Monitoring System that those 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.
  • During 2015, Alere researched, developed, and validated robust software enhancements to mitigate the risk of discrepant low results in certain circumstances.  Alere worked with the FDA from May 2015 through December 2015 to complete activities necessary to submit the software enhancements for review and clearance by the FDA.
  • 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 Alere that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to voluntarily remove the Alere INRatio® device from the market.
  • In light of this input from the FDA and the company’s business considerations, Alere has recently made the decision to voluntarily remove the Alere INRatio® System from the market and to discontinue manufacturing the product after patients transition to an alternate monitoring method.
  • Alere is continuing to work collaboratively with the FDA, as well as other global regulatory authorities regarding details of the product withdrawal. Alere is providing specific communications to its patients, healthcare providers and customers regarding the process to safely transition patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.
2. What is the timetable and process for the product’s withdrawal?
  • Beginning in July 2016, Alere started sending a Medical Device Recall notification to customers with instructions on the product withdrawal.  Alere publicly announced its intent to withdraw the product from the market on Monday, July 11, 2016. Alere has and will continue to collaborate with the FDA and other global regulatory authorities regarding the detailed process for product withdrawal and discontinuation.

3. What Alere INRatio® products are affected (including part numbers) by this removal?
  • This removal includes both the Alere INRatio®/INRatio®2 PT/INR Monitors as well as Alere INRatio® Test Strips used with the monitors.
  • The following part number(s) are affected:

Product Brand Name(s)

Part number(s)

Alere INRatio® PT/INR Test Strips

0100071, 0100139

Alere INRatio®2 PT/INR Test Strips

99007G1 and 99008G1

 

US PART NUMBER RECALLED IN APRIL 2014

PN 99008G2

Alere INRatio® PT/INR System Professional

0100004

INRatio® Prothrombin Time (PT) Monitoring System

0100007

Alere INRatio® PT/INR Replacement Monitor

0100137

Alere INRatio®2 PT/INR Professional Testing System

0200431

Alere INRatio®2 PT/INR Home Monitoring System

0200432

Alere INRatio®2 PT/INR Replacement Monitor (Home)

0200457

Alere INRatio®2 PT/INR Professional Monitoring System

55128A

 

4. Does this mean that Alere is going out of business or will be completely out of the anti-coagulation management business?
  • No. While we will no longer be manufacturing Alere INRatio® Systems, Alere Home Monitoring, Inc. will remain a viable service business which will continue to enable patient self-testing at home.
  • Alere Home Monitoring, Inc. will use non-Alere devices for PT/INR monitoring to service its patient base following withdrawal of the Alere INRatio® System.
  • Alere will also continue to manufacture and sell products other than the Alere INRatio® System.

HEALTHCARE PROFESSIONAL
1. I heard about this notification from the internet/colleague. Why didn’t I receive a notification?
  • If the monitors have been moved within your facilities, Alere would not have a record of this move.
  • Please provide your contact information and we will send you the notification.

 

2. Can I continue to use the Alere INRatio®/INRatio®2 monitor?
  • You may continue to use your Alere INRatio®/INRatio®2 PT/INR Monitor until your patient(s) have transitioned to an alternative monitoring method as long as you ensure that you and your patients (either patients being tested at your facility or your patients who self-test at home) adhere to the precautions and recommendations found in the Medical Device Correction notification of December 2014 and the current Product Insert labeling.  Please transition as soon as possible to an alternate method to perform PT/INR testing, such as a plasma-based laboratory INR method or a point-of-care monitoring system from a different manufacturer.  Refer to www.inr-care.com for more information.
  • We suggest that patients speak with their healthcare providers prior to making any change to their current PT/INR monitoring practices.

 

3. Can I continue to use my strips?
  • You should continue to use your Alere INRatio®/INRatio®2 PT/INR Monitor until your patient(s) have transitioned to an alternate monitoring method as long as you ensure that you and your patients (either patients being tested at your facility or your patients who self-test at home) adhere to the precautions and recommendations found in the Medical Device Correction notification of December 2014 and the current Product Insert labeling.
  • Please transition as soon as possible to an alternate method to perform PT/INR testing, such as a plasma-based laboratory INR method or a point-of-care monitoring system from a different manufacturer Refer to www.inr-care.com for more information.

 

4. Have my satellite offices been notified? Will they be notified? How can I verify that my other labs have been notified?
  • Alere has or will send communications to its patients, healthcare providers and customers regarding the process to safely transition patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.  
  • If the monitors have been moved within your facilities, Alere would not have a record of this.
  • Please verify your other labs have been notified.  If not, please forward the “Urgent Medical Device Recall” letter (including reply form) you received to your other facilities.

 

5. Can patients continue to test on the Alere INRatio®/ INRatio®2 Monitor?
  • Customers should continue to use Alere INRatio® PT/INR test strips until your patient(s) have transitioned to an alternative monitoring method as long as you ensure that you and your patients (either patients being tested at your facility or your patients who self-test at home) adhere to the precautions and recommendations found in the Medical Device Correction notification of December 2014 and the current Product Insert labeling.
  • Please transition as soon as possible to an alternate method to perform PT/INR testing, such as a plasma-based laboratory INR method or a point-of-care monitoring system from a different manufacturer.
  • We suggest that patients speak with their healthcare providers prior to making any change to their current PT/INR monitoring practices.

Questions? Contact Alere

If you have any general inquiries, clinical considerations, or questions about the voluntary withdrawal, please contact
Alere at
1-866-723-2535
or email.