INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothromb...
FDA Recall #Z-0881-2015 — Class I — December 5, 2014
Product Description
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.
Reason for Recall
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.
Recalling Firm
Alere San Diego, Inc. — San Diego, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
231,967 Test Systems including Monitors
Distribution
Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Code Information
All lots of part numbers: 0100004, 0100007, and 0100137.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated