Alere INRatio PT/INR Monitoring Systems Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may report inaccurate INR values, 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 that provides inaccurate diagnostic results, creating a risk of harm through incorrect medication dosing. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alere San Diego, Inc. is initiating a voluntary recall of the Alere INRatio and INRatio 2 Prothrombin Time (PT) Monitoring Systems, including test strips and meters. The recall covers all lots and serial numbers of the affected models.
The recall was initiated because patients using the INRatio systems received therapeutic or near-therapeutic INR results, but subsequent tests performed by central laboratories showed significantly higher INR values outside the therapeutic range. This discrepancy indicates that the device may not be accurately measuring the patient's coagulation status.
The product was distributed worldwide, including in the United States and numerous foreign countries. Patients using these devices should consult their healthcare providers regarding their anticoagulant therapy and follow instructions for proper monitoring.
The recalled product
- Product
- INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring 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
- 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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