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U.S. Department of Health and Human Services

Medical Device Recalls
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Product: pcr
 
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Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCo... 3 02/01/2021 Biomeme, Inc.
CytoScan® Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a mic... 3 06/03/2016 Affymetrix Inc
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocyc... 3 09/15/2014 Biofire Defense
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen... 3 08/08/2014 Nanosphere, Inc.
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutat... 3 08/08/2012 Roche Molecular Systems, Inc.
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60... 3 02/23/2011 Abbott Molecular
Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ... 3 02/23/2011 Abbott Molecular
Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ... 3 02/23/2011 Abbott Molecular
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as a... 3 05/25/2010 Cepheid
Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indicated a... 3 05/25/2010 Cepheid
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