CLASS I Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

Alere INRatio2 PT/INR Professional Monitoring System recalled

Alere San Diego is recalling Alere INRatio2 PT/INR Professional Monitoring System, distributed nationwide in the US. The recall was initiated on 11 Jul 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll Lots All Serial Numbers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2360-2016
FDA event ID: 74665
Recalling firm: Alere San Diego, San Diego, CA
Classification: Class I
Status: Terminated
Recall initiated: 11 Jul 2016
FDA classified: 19 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

11 Jul 2016	Recall initiated by company
19 Aug 2016	Classified by FDA	+39 days
31 Aug 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 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¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

Product as listed by the FDA

Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is not intended to be used for screening purposes.

Where it was distributed

Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.

Nationwide

Questions about this recall

Is Alere INRatio2 PT/INR Professional Monitoring System recalled?

Yes. Alere San Diego recalled Alere INRatio2 PT/INR Professional Monitoring System on 11 Jul 2016. The recall is Class I and its status is Terminated. Recall number Z-2360-2016.

Why was it recalled?

Which lots are affected?

All Lots All Serial Numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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