Alere INRatio 2 Home Monitor Recalled for Inaccurate INR Readings
Alere San Diego is voluntarily recalling INRatio 2 home monitors because they may display inaccurate INR results compared to central laboratory tests.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used to monitor warfarin therapy where inaccurate readings could lead to improper dosing and potential harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Alere San Diego, Inc. is initiating a voluntary recall of the Alere INRatio/INRatio 2 PT/INR Monitoring System, including test strips and meters. The specific product identified is the Alere INRatio2 Replacement Monitor (Home), Model Number 0200457. This device is used for the quantitative determination of the international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time.
The recall was initiated because patients who had a therapeutic or near-therapeutic INR result using the Alere INRatio/INRatio 2 system received significantly higher INR results (outside of the therapeutic range) when tested by a central laboratory. This discrepancy indicates that the home monitoring system may not be providing accurate readings for patients on warfarin therapy.
The recall covers all lots and all serial numbers of the affected product. Distribution was worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. Consumers using this device should stop using it and contact Alere San Diego or their healthcare provider for instructions on how to proceed with their warfarin monitoring.
The recalled product
- Product
- Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 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 d
- Manufacturer
- Alere San Diego, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Alere San Diego, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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