Alere San Diego, Inc. recalls Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips,…

Recall date

December 5, 2014

Source

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

Recall number

Z-0880-2015

FDA classification

Class I

Brand / firm

Alere San Diego, Inc.

Sold / distributed

Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.

Why it was recalled

In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.

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, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).