INRatio 2 PT Monitoring System

• 2 recalls, same reason

  • Terminated Z-2357-2016 FDA Class I ·initiated 11 Jul 2016
  • Terminated Z-2360-2016 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-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-0188-2012 FDA Unclassified (pre-2012) ·initiated 11 Oct 2011 ·on shared 510(k) K072727

  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-1256-2009 FDA Unclassified (pre-2012) ·initiated 23 Dec 2008

  INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.

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

510(k) Number

K072727 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Inratio Self-Test

  Class II

  FDA 510(k) K021923 Active Cleared 24 Oct 2002

• Inratio

  Class II

  FDA 510(k) K020679 Active Cleared 6 May 2002

• What clinical scenarios is the INRatio 2 PT Monitoring System primarily used for?

  The INRatio 2 is designed for real-time monitoring of prothrombin time (PT) and international normalized ratio (INR) in patients on anticoagulant therapy, particularly those using vitamin K antagonists. It is ideal for settings like outpatient clinics, anticoagulation management services, and home monitoring programs where quick, accurate results are needed to guide clinical decisions.

• How is the INRatio 2 PT Monitoring System supplied, and is it reusable?

  The INRatio 2 is supplied as a single-use system, meaning each test cartridge and analyzer combination is intended for one use only. This design eliminates the need for cleaning or reprocessing, reducing the risk of contamination and ensuring consistent performance.

• Does the INRatio 2 require calibration or additional control tests before use?

  No, the INRatio 2 does not require external calibration or separate control tests. Internal quality controls are performed simultaneously with the PT test, streamlining the workflow and ensuring reliable results without extra steps.

• What type of environment is the INRatio 2 intended for, and how should it be stored?

  The INRatio 2 is designed for use in non-sterile environments, such as patient homes or clinics. Storage and handling should follow the manufacturer’s guidelines to maintain device integrity and accuracy, though specific conditions (e.g., temperature, humidity) are not detailed in the provided data.

• What regulatory pathway was followed for the INRatio 2 PT Monitoring System, and what class is it assigned?

  The INRatio 2 was cleared through the FDA’s 510(k) pathway (K072727) as a Class II medical device, with a special clearance type and a decision of substantial equivalence. It falls under the Hematology specialty and is regulated under FDA regulation number 864.7750.