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Alere Recalls Warfarin Test Strips After Receiving Word of Nine Serious Adverse Events, Some of Which Were Associated With Patient Deaths

Filed June 9th, 2014 Laurie

The U.S. Food and Drug Administration (FDA) has given a voluntary recall of Alere Inc.’s PN 99008G2 INRatio2 PT/INR Professional Test Strips a Class I status after receiving reports of nine serious adverse events, three of which described bleeding associated with patient deaths.

A Class I status is the FDA’s most serious recall classification and means that the product can cause potentially deadly adverse events.

Alere explained in a press release that the PN 99008G2 INRatio2 PT/INR Professional Test Strips are intended to test patients taking the blood-thinning drug, warfarin. The strips determine how long it takes blood to clot. Several patients had a therapeutic or near-therapeutic International Normalized Ratio (INR) with the Alere INRatio2 PT/INR Professional Test Strip, but testing performed at a central laboratory returned a significantly higher INR result (outside of therapeutic range).

The recall is limited to PN 99008G2 INRatio2 PT/INR Professional Test Strips and does not include Alere INRatio PT/INR Test Strip (PN 100071), which are used by patients for in-home monitoring. According to the press release, Alere will transition customers from the current INRatio2 PT/INR Professional Test Strip to the INRatio PT/INR Test Strip.

Alere said the patient reports sounded an alarm that the affected strips may report an inaccurately low INR result. The company said that because the root cause of the problem has yet to be undetermined, it has advised its customers to stop using the PN 99008G2 INRatio2 PT/INR Professional Test Strips immediately and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer. Alere also requested that customers return any unused PN 99008G2 INRatio2 PT/INR Professional Test Strips to the company.

Customers with questions regarding the recall may contact Alere at 844-292-5373. Additional information concerning the recall can be found at the company’s website, www.inr-care.com.

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