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U.S. Department of Health and Human Services

Medical Device Recalls

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Product Description
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Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring sys... 1 Aug-19-2016 Alere San Diego, Inc.
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G... 1 Aug-19-2016 Alere San Diego, Inc.
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ® ... 1 Aug-19-2016 Alere San Diego, Inc.
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRat... 1 Aug-19-2016 Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRa... 1 Aug-19-2016 Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRa... 1 Aug-19-2016 Alere San Diego, Inc.
Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Aler... 1 Aug-19-2016 Alere San Diego, Inc.
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 ... 1 Aug-19-2016 Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Al... 1 Aug-19-2016 Alere San Diego, Inc.
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection... 1 Aug-17-2016 OraSure Technologies, Inc.

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