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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 7 of 7 Results
510(K) Number: K092987
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Product Description
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FDA Recall
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Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRa... 1 08/19/2016 Alere San Diego, Inc.
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G... 1 08/19/2016 Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio... 1 01/03/2015 Alere San Diego, Inc.
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin ... 1 01/03/2015 Alere San Diego, Inc.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere IN... 1 01/03/2015 Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Mon... 1 05/08/2014 Alere San Diego, Inc.
0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio... 2 06/24/2011 Alere San Diego
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