Inratio/INRATIO2 Test Strips

• • Terminated Z-2361-2016 FDA Class I ·initiated 11 Jul 2016

  Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 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/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

• • Terminated Z-2362-2016 FDA Class I ·initiated 11 Jul 2016

  Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

• 3 recalls, same reason

  • Terminated Z-0880-2015 FDA Class I ·initiated 5 Dec 2014
  • Terminated Z-0881-2015 FDA Class I ·initiated 5 Dec 2014
  • Terminated Z-0882-2015 FDA Class I ·initiated 5 Dec 2014

  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.

• • Terminated Z-1546-2014 FDA Class I ·initiated 16 Apr 2014

  Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

• • Terminated Z-2661-2011 FDA Unclassified (pre-2012) ·initiated 28 Feb 2011

  The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.

510(k) Number

K092987 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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