Alere San Diego is recalling the Alere INRatio Monitor System, including INRatio Monitor or INRatio2 Monitor and INRatio Test Strips, because they may provide an INR result that is lower than expected result obtained using a laboratory INR method, according to the FDA.
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.
Use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death, according to the FDA.
The system measures how quickly a patient’s blood clots (when taking warfarin, a blood-thinning medicine. The International Normalized Ratio, INR, test is used to compare the results of the patient’s Prothrombin Time.
Use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death.
This recall is not expected to cause a device shortage.