Alere San Diego, Inc. recalls Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform…

Recall date

July 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2361-2016

FDA classification

Class I

Brand / firm

Alere San Diego, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldive…

Why it was recalled

Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.