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?
  • 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.

 

5. How will the Alere INRatio® product withdrawal impact the Alere Home Monitoring business?
  • Alere Home Monitoring, Inc. and Alere San Diego, Inc. are both wholly-owned subsidiaries of Alere Inc.
  • Alere Home Monitoring, Inc. has traditionally used multiple testing platforms in order to provide its healthcare practitioners with alternatives relative to their preferred method of patient care.  The withdrawal of Alere INRatio® will limit available choices for physicians that prescribe Home INR monitoring.  In the short term, Alere Home Monitoring, Inc. will work with its existing vendor to establish a timeline for obtaining alternative equipment and for transitioning patients onto an alternate monitoring device.  While heightened demand for equipment will require time for our vendor to produce the requisite monitor and test supply stock, our intent is to manage this outcome in the least disruptive manner, with respect to our patients and network of healthcare providers.  Given its current use and familiarity with the alternate monitor, Alere Home Monitoring, Inc. does not anticipate any long-term disruption with respect to its ability to support patients transitioned from the Alere INRatio® System.

PATIENT SELF-TESTERS
1. Can I continue to use my monitor?
  • Please contact your healthcare provider as soon as possible to discuss how to safely transition to an alternate method of PT/INR testing.  We suggest that you speak with your healthcare provider before making any change to your current PT/INR monitoring practices.
  • You should continue to use your Alere INRatio® PT/INR Monitor until you have worked with your healthcare provider to safely transition to an alternative monitoring method as long as you and your healthcare provider adhere to the precautions found in the Medical Device Correction notification of December 2014 and the current Alere INRatio® Product labeling

 

2. What are alternatives for at home testing?
  • Please contact your healthcare provider or Home INR Testing Service (IDTF) for testing alternatives.

 

3. Don’t you provide my Home INR Testing Service?
  • We are Alere San Diego, Inc. the manufacturer of the monitor. Many Home INR Testing Services provide the Alere INRatio® device for home use. Alere Home Monitoring, Inc. is one such home INR Testing Service that provides the Alere INRatio® device. Alere Home Monitoring, Inc. and Alere San Diego, Inc. are both wholly-owned subsidiaries of Alere Inc.

 

4. I want to stop testing at home? How do I send my monitor back?
  • Your healthcare provider may prefer you to continue with Home INR Monitoring and may prescribe an alternative point-of-care monitor. If you elect not to continue monitoring at home, you will need to arrange alternative testing at a healthcare provider’s office or lab with your health care professional. Please contact your healthcare provider before making changes to your anticoagulation monitoring.

 

5. Can I get a different monitor that is not an Alere INRatio®/ INRatio®2 monitor?
  • Yes, your healthcare provider may decide to switch you to an alternative point-of-care monitor or prescribe testing at a laboratory. The type of device you are using for your test is prescribed by your physician. Your healthcare provider was notified, and, if he or she submits a change to your prescription, your Home INR Testing Service (IDTF) will contact you to work on placing you with an alternative monitor.
  • You should discuss this directly with your healthcare provider if you have concerns. If you would like to continue to test at home, your current Home INR Testing Service (IDTF) will work with you and your healthcare provider to transition to an alternate monitor so that your INR monitoring is not disrupted.
  • You should continue to use your Alere INRatio® PT/INR Monitor until you have worked with your healthcare provider to safely transition to an alternate monitoring method as long as you and your healthcare provider adhere to the precautions found in the Medical Device Correction notification of December 2014 and the current Alere INRatio® Product labeling.

6. Do I need to send the monitor and response form back at the same time using the shipping bag provided?
  • Please send back the completed response form using the pre-paid envelope within 10 days.  Please keep your monitor until you have safely transitioned to an alternate method of testing your PT-INR.  Once you have safely transitioned, you can use the plastic shipping bag and pre-paid shipping label to return your monitor or dispose of the monitor according to the instructions in the recall letter.

 

7. I have already consulted with my healthcare provider and transitioned to an alternate method of PT/INR testing, do I need to do something else since I received the notification?
  • Yes, please follow the instructions in the recall letter, complete the Reply Form and mail it back to Alere using the enclosed postage-paid envelope, fax back to 1-888-656-6380 or e-mail to Alere5191@stericycle.com.

 

8. I have already returned my monitor and now I can’t test, what do
    I do now?
  • Please contact your healthcare provider and Home INR testing Service (IDTF) immediately to discuss how to safely transition to an alternate solution that will allow you to safely continue anti-coagulation monitoring in the least disruptive manner possible

 

9. How do I dispose of my unused Alere INRatio® Test Strips?
  • We recommend that you cut up the test strips with scissors prior to disposal.  Please use caution when handling the strips after cutting them up for disposal, as the exposed edges of the strip may be sharp.

 

10. How do I dispose of my Alere INRatio®/INRatio®2 PT/INR Monitor?
  • Deliver your Alere INRatio®/INRatio®2 PT/INR Monitor monitors to a local, electronic hazardous waste facility.

 

11. I received the return materials that came with the notification letter, what do you want me to do with them?
  • If you are unable to dispose of your monitor and/or test strips, please clean the monitor by following the Cleaning Instructions per the User Guide.  Please put the monitor in the white plastic shipping envelope provided with the letter, affix the return label on the envelope and return the monitor.  Place the shipping envelope can be given to any UPS driver or taken to any location of The UPS Store, a UPS Drop Box, a UPS Customer Center, any Staples location, or any UPS Authorized Shipping Outlet.  There is no charge to drop off a prepaid return envelope.

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.