Alere INRatio PT/INR System Recalled for Inaccurate Warfarin Monitoring Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may show lower INR values than central laboratory tests, potentially affecting warfarin dosing.
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 and INRatio 2 PT/INR Monitoring Systems, including test strips and meters. The recall covers model number 0100004 and all lots and serial numbers. The product is an in vitro diagnostic device used by health care professionals to monitor the effect of warfarin on clotting time in fresh capillary whole blood.
The recall was initiated because patients who had a therapeutic or near-therapeutic INR result using the Alere system were found to have significantly higher INR values (outside the therapeutic range) when tested by a central laboratory. This discrepancy indicates that the device may not accurately reflect the patient's actual clotting status compared to standard laboratory methods.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. Health care professionals using these devices should stop using them and contact Alere San Diego for further instructions. Consumers should not use these devices for self-monitoring or make medication changes based on these results without consulting their healthcare provider.
The recalled product
- Product
- Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test…
- 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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