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A recall has been issued for Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use). The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) may provide an INR result that is lower than expected result obtained using a laboratory INR method. Incorrect results can also occur if a patient has certain medical conditions. These conditions include, anemia, conditions associated with elevated fibrinogen levels, or unusual bleeding or bruising. Incorrect results can also occur if the instructions in the labeling for performing the test are not followed. (See Healthcare Professional letter or Patient letter). Use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death. Alere received 18,924 reports of incidents in which the device has malfunctioned, including 14 serious injuries. According to the firm, all affected devices may fail. This recall is not expected to cause a device shortage. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm429496.htm
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