Alere INRatio2 PT/INR Monitoring System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Monitoring Systems because they may report inaccurate INR results, potentially leading to incorrect anticoagulant dosing.
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 for critical anticoagulant monitoring where inaccurate results pose a risk of harm (under- or over-anticoagulation), but the source text does not report specific injuries or fatalities, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Alere San Diego, Inc. is initiating a voluntary recall of the Alere INRatio/INRatio2 PT/INR Monitoring Systems, which include test strips and meters. The recall covers all lots and serial numbers of the device, which is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood for professional and home use by individuals taking warfarin or other oral anticoagulant therapy.
The recall was initiated because patients using the Alere INRatio/INRatio2 system received therapeutic or near-therapeutic INR results, but subsequent testing by a central laboratory revealed significantly higher INR values outside the therapeutic range. This discrepancy indicates that the device may not accurately reflect the patient's actual clotting time.
The product was distributed worldwide, including the United States and numerous foreign countries. Consumers and healthcare professionals using this device should stop using it and contact Alere San Diego for instructions on how to proceed with their anticoagulant monitoring.
The recalled product
- Product
- 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 re
- 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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