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

Alere INRatio2 PT/INR Home Monitoring System recalled by Alere San Diego

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

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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-2358-2016
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 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¿/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 Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home 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

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

Other products in this recall event

8 other products · FDA event 74665

This product is part of a recall event; the main page for the event is Alere INRatio PT/INR Test Strips recalled by Alere San Diego.

Reported	Class	Recall	Company	Reason	Where
31 Aug 2016	CLASS I	Alere INRatio PT/INR Test Strips recalled by Alere San Diego	Alere San Diego	Temperature Abuse	Nationwide
31 Aug 2016	CLASS I	Alere INRatio2 Replacement Monitor (Home) recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016	CLASS I	Alere INRatio2 PT/INR Professional Monitoring System recalled	Alere San Diego	Other	Nationwide
31 Aug 2016	CLASS I	Alere INRatio/ INRatio2 PT/INR Test Strips recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016	CLASS I	Alere INRatio2 PT/INR Professional Testing System recalled	Alere San Diego	Other	Nationwide
31 Aug 2016	CLASS I	Alere INRatio Replacement Monitor recalled by Alere San Diego	Alere San Diego	Other	Nationwide
31 Aug 2016	CLASS I	INRatio Prothrombin Time (PT) Monitoring System recalled	Alere San Diego	Other	Nationwide
31 Aug 2016	CLASS I	Alere INRatio PT/INR System Professional recalled by Alere San Diego	Alere San Diego	Other	Nationwide

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