Alere INRatio2 PT/INR Home Monitoring System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems 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 results could lead to improper dosing, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Alere San Diego, Inc. is initiating a voluntary recall of the Alere INRatio/INRatio2 PT/INR Monitoring System, including test strips and meters. The recall covers model numbers 0200432 and 0200433, all lots, and all serial numbers. The product 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 is being initiated because patients who had a therapeutic or near-therapeutic INR when using the Alere INRatio/INRatio2 system showed a significantly higher INR, outside of the therapeutic range, when the test was performed by a central laboratory. This discrepancy indicates that the home monitoring system may not accurately reflect the patient's actual clotting status.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. Consumers and healthcare providers should stop using the recalled devices and test strips and contact their healthcare provider or Alere San Diego for further instructions on how to proceed with monitoring warfarin therapy.
The recalled product
- Product
- Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 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 qu
- 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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