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www.fdanews.com/articles/169604-alere-san-diego-recalling-all-inr-monitoring-systems
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Alere San Diego Recalling All INR Monitoring Systems

January 16, 2015

Alere San Diego is recalling all of its Alere INRatio and INRatio 2PT/INR Monitor Systems and INRatio Test Strips because they may provide an international normalized ratio that is lower than the expected result derived from a laboratory INR test.

Using the recalled devices may result in a treatment delay resulting in severe or life-threatening injuries or death, according to a recall notice posted recently to the FDA’s website. The agency designated the recall Class I, the most serious type.

The tests are designed to measure how quickly a patient’s blood clots when taking the blood-thinning medicine warfarin, allowing healthcare providers to better monitor the patient’s anticoagulation status, the notice says.

The San Diego, Calif., company sent an “Urgent Medical Device Correction” letter to customers on Dec. 5 asking them to stop using the products if patients have specific conditions. Alere received nearly 19,000 reports of incidents in which the device malfunctioned, including 14 that resulted in serious injuries, the notice says.

Alere does not expect the recall to cause a device shortage. The recall includes all units manufactured and distributed between April 1, 2008 and December 4, 2014.

View the recall notice at http://www.fdanews.com/01-20-15-AlereRecall.pdf. — Kellen Owings