Alere Home Monitoring Device Attorneys
Alere® INRatio / INRatio2 Monitor & Test Strips
Back on December 8, 2014, Alere sent a letter to it’s U.S. Consumers notifying them of important information in regards to their Alere INRatio (or INRation2) test monitor and test strips. The letter stated the FDA recall has 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 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, strokes or mini-strokes and 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.
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
If you believe that you or someone you know may have developed bleeding events, subdural hematomas, strokes or mini-strokes or suffered other harmful side effects after using Alere®, please contact us now for a free, confidential consultation.