Alere INRatio 2 Home Monitor Recalled for Inaccurate INR Readings
Alere San Diego is voluntarily recalling INRatio 2 home monitors because they may display inaccurate INR results compared to central laboratory tests.
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 System (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, Inc. is initiating a voluntary recall of the Alere INRatio/INRatio 2 PT/INR Monitoring System, including test strips and meters. The specific product identified is the Alere INRatio2 Replacement Monitor (Home), Model Number 0200457. This device 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 was initiated because patients who had a therapeutic or near-therapeutic INR result using the Alere INRatio/INRatio 2 system received significantly higher INR results (outside of the therapeutic range) when tested by a central laboratory. This discrepancy indicates that the home monitoring system may not be providing accurate readings for patients on warfarin therapy.
The recall covers all lots and all serial numbers of the affected product. Distribution was worldwide, including the United States and numerous foreign countries such as Argentina, Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. Consumers using this device should stop using it and contact Alere San Diego or their healthcare provider for instructions on how to proceed with their warfarin monitoring.
The recalled product
- Product
- Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 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 quantitative…
- 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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