Alere INRatio2 PT/INR Home Monitoring System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems 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/INRatio2 PT/INR Monitoring System, including test strips and meters. The recall covers model numbers 0200432 and 0200433, all lots, and all serial numbers. The product 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 is being initiated because patients who had a therapeutic or near-therapeutic INR when using the Alere INRatio/INRatio2 system showed a significantly higher INR, outside of the therapeutic range, when the test was performed by a central laboratory. This discrepancy indicates that the home monitoring system may not accurately reflect the patient's actual clotting status.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. Consumers and healthcare providers should stop using the recalled devices and test strips and contact their healthcare provider or Alere San Diego for further instructions on how to proceed with monitoring warfarin therapy.
The recalled product
- Product
- Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 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…
- 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.
See all 9 products in this recall →Related recalls
Same manufacturer · Alere San Diego, Inc.
See all →- ModerateAlere hCG Urine Test Strips Recalled for False Positive Risk
FDA (Devices) · 2026-10-07
- HighAlere hCG Pregnancy Test Cassettes Recalled for False Positive Results
FDA (Devices) · 2026-10-07
- ModerateAlere Recalls hCG Pregnancy Tests Due to False Positive Risk
FDA (Devices) · 2026-10-07
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighAbbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
FDA (Devices) · 2024-05-08
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- SevereAlere INRatio 2 Monitors Recalled for Potential Inaccurate INR Results
FDA (Devices) · 2015-01-14
- SevereAlere INRatio2 Test Strips Recalled for Inaccurate INR Results
FDA (Devices) · 2014-05-14
- SevereAlere INRatio Monitors Recalled for Potential Inaccurate INR Results
FDA (Devices) · 2015-01-14
- SevereAlere INRatio PT/INR Test Strips Recalled for Inaccurate Results
FDA (Devices) · 2015-01-14
- HighAlere Triage Tox+MTD Drug Screen Recalled for Decreased Precision and Accuracy
FDA (Devices) · 2012-07-25
- SevereAlere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results
FDA (Devices) · 2012-07-18