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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 5 of 5 Results
510(K) Number: K110212
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Product Description
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Recall
Class
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FDA Recall
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Recalling Firm
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Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ® ... 1 08/19/2016 Alere San Diego, Inc.
Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Aler... 1 08/19/2016 Alere San Diego, Inc.
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 ... 1 08/19/2016 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 INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio... 1 01/03/2015 Alere San Diego, Inc.
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