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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with…"
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…
- 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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