Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - Recalled by Alere San Diego, Inc. Due to In certain cases, an INRatio PT/INR Monitor system...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alere San Diego, Inc. directly.
Affected Products
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
Quantity: 231,967 Test Systems including Monitors
Why Was This Recalled?
In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alere San Diego, Inc.
Alere San Diego, Inc. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report