Inratio

• 2 recalls, same reason

  • Terminated Z-2355-2016 FDA Class I ·initiated 11 Jul 2016
  • Terminated Z-2356-2016 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.

• 2 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

  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-0188-2012 FDA Unclassified (pre-2012) ·initiated 11 Oct 2011 ·on shared 510(k) K020679

  Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.

• • Terminated Z-0132-06 FDA Unclassified (pre-2012) ·initiated 7 Sep 2005

  A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K020679 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• INRatio 2 PT Monitoring System

  Class II

  FDA 510(k) K072727 Active Cleared 26 Oct 2007

• Inratio Self-Test

  Class II

  FDA 510(k) K021923 Active Cleared 24 Oct 2002