FDA Recalls Blood Clot Testing Strips

Weitz & Luxenberg is currently investigating claims surrounding a medical recall, the target of which may be responsible for three consumer deaths.

The FDA has issued a Class I Recall of Alere San Diego Inc.’s INRatio2 PT/INR Professional Test Strips, which have been linked to at least nine malfunctions resulting in six injuries and three bleeding-related deaths.

Alere’s INRatio2 PT/INR Professional Test Strips are intended for use in patients who must regularly monitor their PT or INR to ensure proper dosing of the blood-thinning medication warfarin. The FDA has issued its most serious recall, a Class I recall, in response to reported incidences of incorrect readings where the strips found normal INR results within or just above the acceptable therapeutic range, which later health care center testing done due to several patients’ deteriorating conditions determined were much higher, outside of the therapeutic range.

A PT (prothrombin time) test, also known as an INR (international normalized ratio) test, is a blood test used to measure the time it takes for blood to clot, reported in an internationally standardized way so that results are interpretable no matter the method of testing.

Maintaining proper PT/INR levels is important for many patients, as levels that are too high or too low can, in some cases, lead to the development of serious blood clots or bleeding, and thus it is imperative for devices that monitor these levels to be accurate.

The Class I Recall from the FDA is available here. If you or a loved one have been injured due to incorrect test results from Alere’s INRatio2 PT/INR Professional Test Strips, call us today to evaluate the viability of your claim.

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