Alere INRatio2 PT/INR Testing System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Testing Systems because some patients showed significantly higher INR results in central laboratories than on the device.
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 blood thinning therapy where inaccurate results could lead to improper medication management. The source text describes a discrepancy in results but does not report specific injuries, hospitalizations, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alere San Diego is initiating a voluntary recall for the Alere INRatio and INRatio2 PT/INR Monitoring Systems, which include test strips and meters. The recall covers all lots and serial numbers of the product.
The recall was initiated because some patients had a therapeutic or near-therapeutic INR result when using the Alere INRatio or INRatio2 system, but a significantly higher INR result (outside of the therapeutic range) when the test was performed by a central laboratory. The system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood by people taking warfarin and other oral anticoagulant therapy who need to monitor their blood clotting time.
The product was distributed worldwide, including in the United States and numerous foreign countries. The source text does not specify the number of affected units or the number of patients impacted. Consumers and healthcare providers should stop using the recalled devices and contact Alere San Diego for further instructions.
The recalled product
- Product
- Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use
- 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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