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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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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 ...
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1
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08/19/2016
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Alere San Diego, Inc.
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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...
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1
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08/19/2016
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Alere San Diego, Inc.
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