Alere plans to remove its INRatio and INRatio2 PT/INR monitoring system from the market and to discontinue manufacturing the product line following a Class I recall due to inaccurate test results.
The INRatio system measures blood clotting time for people taking blood thinner warfarin.
According to the Aug. 25 FDA notice, the INRatio system may generate an incorrect low result using a plasma-based INR method. If an incorrect result is acted upon, such as lowering the warfarin dose, patients could be at risk for fatal bleeding.
Alere was not able to develop an adequate modification and is thus halting manufacturing the product line, the FDA said.
Healthcare providers were advised to transition patients to an alternate method of PT/INR testing as soon as possible. Alere will continue to manufacture and distribute the test strips for a period of time to allow patients to safely transition to another monitoring method.
In a July 26 urgent recall notice to customers, Alere announced that it was voluntarily removing the product line from the market. The company noted that it issued a voluntary correction in December 2014, informing healthcare providers that the monitoring system should not be used for patients with certain medical conditions.
Advocacy group Public Citizen raised the red flag on the blood testing devices in December 2015. At that time, the advocacy group said its analysis of the FDA’s Manufacturer and User Facility Device Experience database showed 9,469 malfunction reports and 1,445 injury reports from 2002 through November 2015 with INRatio devices ().
A Class I recall is the most serious type of recall, because use can result in serious injury or death. Read the FDA notice here for the full list of affected products: www.fdanews.com/08-25-16-Alertrecall.pdf. — Tamra Sami