During December 2014, Alere Inc. initiated a recall of its Alere INRatio® and INRatio®2 PT/INR Monitor Systems after the medical device provided falsely low INR rest results.
Alere sent a letter to U.S. consumers on Dec. 8, 2014, notifying them of important information concerning their Alere INRatio (or INRatio2) Test Strips and Monitor System. Individuals use the Alere INRatio monitor system and test strips to monitor their blood clotting time (PT/INR) while they are on warfarin therapy. Warfarin is also marketed by the brand names Coumadin, Jantoven, Marevan, Uniwarfin and is an anticoagulant used to prevent thromboembolism, thrombosis, and blood clots.
The letter, which was titled “URGENT: MEDICAL DEVICE CORRECTION,” advised consumers the steps they should take to protect their health and safety when using the INRatio PT/INR monitor system as well as certain conditions which may put them at risk of an adverse event when using the device.
Why did I receive a letter about Alere’s INRatio monitor system?
You received the letter because Alere believes you or someone at your address uses or has used Alere’s INRatio PT/INR monitor system. The purpose of the letter was to inform consumers with certain medical who were using the Alere INRatio PT/INR test strip and monitor system that an FDA recall had been issued for the device. In the letter, Alere listed several medical conditions which could affect the accuracy of INR readings given to consumers. These conditions include:
- Anemia (low hemoglobin or red blood cell count)
- Unusual or unexplained bleeding and/or bruising
- Conditions which produce elevated levels of fibrinogen such as:
- Acute inflammatory conditions like pneumonia or influenza,
- Chronic inflammatory conditions like rheumatoid arthritis, Crohn’s disease, ulcerative colitis, hepatitis and other infectious liver diseases or inflammatory kidney diseases,
- Severe infections such as sepsis, or
- Advanced stages of cancer or end stage renal disease requiring hemodialysis
Alere recalled its INRatio PT/INR test strips and monitor systems manufactured between April 2008 and December 2014. The company recommends that individuals discuss the recall with their doctor. Alere said patients should switch to laboratory INR monitoring of their PT/INR levels while taking warfarin.
What problem with the Alere INRatio monitor system is the letter addressing?
Users of the Alere INRatio monitor system may receive results that indicate the individual’s INR level is within the therapeutic range. However, Alere has admitted that its INRatio monitor system can provide INR results that are significantly lower than accurate. This lower-than-accurate result puts INRatio users at risk for serious health complications and even death. So far, three deaths and six serious injuries have been reportedly associated by Alere INRatio test strips and the Alere INRatio monitor system has been the subject of almost 19,000 complaints.
What advice does the Alere INRatio letter offer?
First, talk with your doctor about the recall. Second, Alere urges users to carefully follow the directions for using its INRatio monitor system and test strips, including the following:
- If your INR result falls within the therapeutic range but you have delayed clotting symptoms like bleeding or bruising, talk to your doctor immediately.
- Don’t use the Alere INRatio monitor system if your hematocrit is outside a range of 30% to 55%. Alere recommends contacting your doctor to get a hematocrit measurement if you have not received a recent measurement.
- Do not apply more than one large drop of blood to the Alere INRatio test strip after the test has begun.
- Keep your Alere INRatio monitor on a stable surface and do not move it during the test.
- Have your doctor measure your INR using a plasma-based laboratory INR method.
Why was a Class I FDA recall issued for the Alere INRatio PT/INR monitor system?
Alere issued a recall for its INRatio PT/INR test strip and monitor system because it may produce inaccurate (usually too low) INR readings. By using this medical device, consumers may be at risk of severe injuries such as bleeding events, subdural hematomas, or even death.
The U.S. Food and Drug Administration (FDA) reports Alere admitted to receiving almost 19,000 complaints of malfunction by INRatio users. The FDA has classified this recall as a Class I recall, the most serious category of recall. Class I recalls involve situations where the use of a medical device will likely cause a serious injury or death to a consumer.
What Alere INRatio monitor system and test strips does the recall apply to?
The urgent medical device correction applies to the following Alere INRatio models:
- Alere INRatio Test Strips:
- 0100071 Alere INRatio PT/INR Test Strips, Box of 12
- 0100139 Alere INRatio PT/INR Test Strips, Box of 48
- Alere INRatio Monitors:
- 0100004 Alere INRatio PT/INR System Professional
- 0100007 INRatio Prothrombin Time (PT) Monitoring System
- Alere INRatio2 Monitors:
- 0200431 Alere INRatio 2PT/INR Professional Testing System
- 0200432 Alere INRatio PT/INR Home Monitoring System
- 55128A Alere INRatio PT/INR Professional Monitoring System
- 55130 Alere INRatio PT/INR Monitor
Why is The Cochran Firm investigating the Alere INRatio monitor system?
The Cochran Firm, D.C. is actively investigating claims of serious injury from the use of the Alere INRatio PT/INR monitoring system and whether Alere knew or should have known the risk of malfunction but delayed its recall. Alere has a duty to produce a reliable product which its consumers rely upon for their health and safety. The Cochran Firm, D.C. fights for the rights of those who are injured by defective medical devices and are ready to help recover lost wages, medical bills, pain and suffering, and other damages.
If you or a loved one was severely injured or died while using an Alere INRatio PT/INR monitor system or test strips, you may be eligible for substantial compensation. The Cochran Firm, D.C. has a team of dedicated and experienced attorneys ready to help.
Please call us at 1-800-THE-FIRM (843-3476) or 202-682-5800. You can also fill out a contact form and we will get in touch. Because strict time deadlines apply when filing an Alere INRatio claim, please contact us at your earliest convenience in order to preserve your rights.
We are offering prompt, confidential, and 100% free case reviews for users of the Alere INRatio and INRatio2 PT/INR monitor system and test strips. There is no fee unless we recover damages for you.