New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.

Alere recalls INRatio and INRatio2 PT/INR Monitor System

The firm received 18,924 reports of incidents, including 14 serious injuries.

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.

Discover the right packaging solutions for life sciences in Philadelphia
Explore innovative packaging and supply chain solutions for the life sciences at the largest PACK EXPO East in history, March 18–20. Get ideas from 400+ top exhibitors and connect with colleagues and industry experts—all in one convenient location!
Read More
Discover the right packaging solutions for life sciences in Philadelphia
Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Read More
Test Your Supply Chain Smarts