CLASS I Device recall · Reported 14 Jan 2015 · FDA Enforcement Report

INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR recalled

Alere San Diego is recalling INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432, distributed nationwide in the US. The recall was initiated on 5 Dec 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll lots of part numbers 0200431, 0200432, 0200433, 0200457, 55112, 55131, and 55128A.

Quantity recalled231,967 Test Systems including Monitors

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-0882-2015
FDA event ID: 69964
Recalling firm: Alere San Diego, San Diego, CA
Classification: Class I
Status: Terminated
Recall initiated: 5 Dec 2014
FDA classified: 3 Jan 2015
Reported: 14 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Insulin Pumps & Glucose Monitors

Timeline

5 Dec 2014	Recall initiated by company
3 Jan 2015	Classified by FDA	+29 days
14 Jan 2015	Published in enforcement report	+11 days

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

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere INRatio 2 Replacement Monitor - 55128A Alere INRatio 2 PT/INR Professional Monitoring System The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.

Where it was distributed

Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots of part numbers 0200431, 0200432, 0200433, 0200457, 55112, 55131, and 55128A.

Where was it sold?

Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.

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

2 other products · FDA event 69964

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
14 Jan 2015	CLASS I	Alere INRatio PT/INR Test Strips recalled by Alere San Diego	Alere San Diego	Packaging Defects	Nationwide
14 Jan 2015	CLASS I	INRatio Monitors - 0100004 Alere INRatio PT/INR System recalled	Alere San Diego	Packaging Defects	Nationwide

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