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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K122514
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Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test 2 08/08/2024 Luminex Corporation
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test,... 2 12/06/2023 Luminex Corporation
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 2 07/02/2021 Luminex Corporation
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC... 2 08/10/2020 Luminex Corporation
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Cult... 3 02/11/2019 Luminex Corporation
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product... 2 11/10/2018 Luminex Corporation
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitativ... 2 09/30/2014 Nanosphere, Inc.
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-res... 2 09/23/2014 Nanosphere, Inc.
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