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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-2355-2016 - INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop... 1 08/19/2016 Alere San Diego, Inc.
Z-2359-2016 - Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the ... 1 08/19/2016 Alere San Diego, Inc.
Z-2357-2016 - Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fres... 1 08/19/2016 Alere San Diego, Inc.
Z-2360-2016 - Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio®/INRatio®2 system uses a modified version of the one-stage PT test. After a drop of bloo... 1 08/19/2016 Alere San Diego, Inc.
Z-2358-2016 - 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, consis... 1 08/19/2016 Alere San Diego, Inc.
Z-2362-2016 - Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio®/INRatio®2 syste... 1 08/19/2016 Alere San Diego, Inc.
Z-2356-2016 - Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole bloo... 1 08/19/2016 Alere San Diego, Inc.
Z-2361-2016 - Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombin... 1 08/19/2016 Alere San Diego, Inc.
Z-2354-2016 - 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 (Profe... 1 08/19/2016 Alere San Diego, Inc.
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