Alere INRatio PT/INR Test Strips Recalled for Inaccurate INR Readings
Alere San Diego is voluntarily recalling INRatio PT/INR test strips and meters because they may display therapeutic INR values that are significantly higher in central laboratory testing.
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 for a critical therapeutic parameter (INR), creating a risk of harm due to incorrect anticoagulation management, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Alere San Diego, Inc. is initiating a voluntary recall of the Alere INRatio and INRatio2 PT/INR Monitoring Systems, which include test strips and meters. The recall covers model numbers 0100071 and 0100139. The products were distributed worldwide, including in the United States and numerous foreign countries.
The recall is being conducted because patients using the Alere INRatio or INRatio2 system received therapeutic or near-therapeutic INR results, but subsequent testing by a central laboratory revealed significantly higher INR values that were outside the therapeutic range. This discrepancy indicates that the device may not accurately reflect the patient's coagulation status.
The source text does not specify the number of affected units, specific lot numbers, or dates of distribution. Consumers and healthcare providers should stop using the recalled test strips and meters and consult their healthcare provider for alternative INR monitoring methods.
The recalled product
- Product
- Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reacti
- 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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