FDADecember 5, 2014device
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere I...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
alere san diegoalerealere san
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCDemlar Recalls MoonSoll and Magic Chems Fuel Bottles Due to Risk of Serious Injury or Death from Flash Fire; Violates Mandatory Standard for Portable Fuel Containers and FHSA Labeling Requirements; Imported by Demlar Online Store2025-11-20
- FDAMi More snacks, Coco Bandera, 3 oz. Plastic container, 8 per container, 20 per case box2024-12-04
- USDA FSISFSIS Issues Public Health Alert for Raw Pork Chorizo Products Due to Possible Foreign Matter Contamination2024-05-02
- FDA3-ounce H-E-B Creamy Creations Ice Cream Homemade/Chocolate Combo -12 pack2024-04-27
- FDA3-ounce H-E-B Creamy Creations Chocolate Ice Cream-12 pk2024-04-27
- FDA3-ounce H-E-B Creamy Creations Ice Cream Lime/Orange Combo - 12 pack2024-04-27
- FDAAbbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 551702024-03-01
- FDAREF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 22922023-06-09
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