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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
510(K) Number: K021923
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Product Description
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Recall
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FDA Recall
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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.
PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Pr... 2 11/16/2011 Alere San Diego
HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is ... 2 11/15/2005 HemoSense Inc
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