MEDICAL DEVICE ALERA UPGRADED TO A CLASS I RECALL BY FDA

The FDA (Food and Drug Administration) has recently upgraded the recall of Alere INRatio and INRatio2 Monitor systems to a Class I recall. This means that there is a probability that using the Alere system will cause serious health consequences or possibly lead to death.

The Alere system was originally recalled last year for providing falsely low international normalized ratio levels in patients who were using blood thinners such as warfarin.
Alere’s monitor system measures how quickly a patient’s blood clots, specifically their Prothrombin Time (PT) when on certain blood tinning medications. Because warfarin and other blood thinners block vitamin K, the medicines prevent clots from easily forming.
The recall was based on the device misreading INR (International Normalized Ratio) levels. Nearly 19,000 reports of device malfunctions, including 14 which resulted in serious injury have been reported. A press release from Alere acknowledged that the false levels resulting from the use of their Alere Pt/INR test strips had resulted in the company receiving “serious adverse event reports,” some of which “described bleeding associated with patient deaths.”
According to the FDA, “use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death,” and that patients suffering from certain medical conditions, including but not limited to anemia, acute or chronic inflammatory conditions, severe infections, and advanced-stage cancer or end stage renal disease, should not use the Alere INRatio and INRatio 2 Monitoring systems and test strips.”
Patients affected by these conditions were instead instructed to stop using the Alere INRatio and InRatio2 Monitoring Systems and test strips, and “should immediately be transitioned to a laboratory INR method for monitoring for their INR and warfarin therapy,” said FDA documents.
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