Alere INRatio PT Monitoring Systems Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio PT Monitoring Systems because they may show lower INR results than central laboratory tests, potentially affecting warfarin therapy.
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, Inc. is initiating a voluntary recall of the Alere INRatio and INRatio 2 PT/INR Monitoring Systems, including test strips and meters. The recall affects all lots and serial numbers of the Alere INRatio Replacement Monitor, Model Number 0100137.
The recall was initiated because patients using the Alere system showed therapeutic or near-therapeutic INR results, but subsequent tests performed by central laboratories revealed significantly higher INR levels outside the therapeutic range. The INRatio 2 PT Monitoring system is intended for in vitro diagnostic use by people taking warfarin and other oral anticoagulant therapy who need to monitor their blood clotting time.
The product was distributed worldwide, including the United States and numerous foreign countries. Consumers using these devices should contact their healthcare provider for further instructions regarding their anticoagulant therapy and testing.
The recalled product
- Product
- Alere INRatio Replacement Monitor Model Number: 0100137 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 use outside the body (in…
- 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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