INRATIO2 Pi/Nr Monitoring System; Inratio Pt/Inr Test Strip

510(k) K110212

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESU Traditional	NumberK110212	Date1 May 2012Cleared	StatusActive

5 recalls · FDA

3 recalls, same reason
- Terminated Z-2359-2016 FDA Class I initiated 11 Jul 2016
- Terminated Z-2354-2016 FDA Class I initiated 11 Jul 2016
- Terminated Z-2358-2016 FDA Class I initiated 11 Jul 2016
Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K110212
FDA Product Code: GJS
Models / Variants: INRATIO2 Pi/Nr Monitoring System
Inratio Pt/Inr Test Strip