On December 3, Alere apparently sent out a 'Self Test Customer Letter' to some (probably not all) of its self-test customers. Alere is aware that, for a while, I was using the InRatio, but I haven't received the letter. Perhaps only those who use the Alere blood monitoring service were included in this letter.
he title of the letter is "URGENT:MEDICAL DEVICE CORRECTION", and it reports that 'in certain cases an InRatio..system may provide an INR result that is significantly lower than a result obtained u sing a laboratory INR system." (This information is contrary to my personal experience with the InRatio, which was always higher than the labs or my Coat-Sense meter).
The letter goes on to state that the issue can arise if you have certain medical conditions -- these inlude Anemia, acute inflammatory conditions, chronic inflammatory conditions (rheumatoid arthritis, Crohn's disease, and other fun ailments), severe infection, advanced stage cancer or end stage renal disease, or any bleeding or unusual bruising.
The notice goes on to suggest that you discuss this with your doctor, and also suggests that you have your INR tested using a laboratory INR method.
I don't have a link for these notices, but Alere has established an 'Alere InRatio Recall Hotline' at 877 929 2579, and a website with answers to frequently asked questions -- www.inr-care.com.
I won't speculate on how this information, combined with a strip recall and limited availability of strips will impact the future of the InRatio devices for testing (self-testing, or testing at medical facilities) INR.
he title of the letter is "URGENT:MEDICAL DEVICE CORRECTION", and it reports that 'in certain cases an InRatio..system may provide an INR result that is significantly lower than a result obtained u sing a laboratory INR system." (This information is contrary to my personal experience with the InRatio, which was always higher than the labs or my Coat-Sense meter).
The letter goes on to state that the issue can arise if you have certain medical conditions -- these inlude Anemia, acute inflammatory conditions, chronic inflammatory conditions (rheumatoid arthritis, Crohn's disease, and other fun ailments), severe infection, advanced stage cancer or end stage renal disease, or any bleeding or unusual bruising.
The notice goes on to suggest that you discuss this with your doctor, and also suggests that you have your INR tested using a laboratory INR method.
I don't have a link for these notices, but Alere has established an 'Alere InRatio Recall Hotline' at 877 929 2579, and a website with answers to frequently asked questions -- www.inr-care.com.
I won't speculate on how this information, combined with a strip recall and limited availability of strips will impact the future of the InRatio devices for testing (self-testing, or testing at medical facilities) INR.