Medical Device Recalls

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510(K) Number: K122514

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Product Description	Recall Class	FDA Recall Posting Date	Recalling Firm
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Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Cult...	3	02/11/2019	FEI # 3002524000 Luminex Corporation
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test	2	08/08/2024	FEI # 3006028115 Luminex Corporation
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test,...	2	12/06/2023	FEI # 3006028115 Luminex Corporation
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018	2	07/02/2021	FEI # 3006028115 Luminex Corporation
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC...	2	08/10/2020	FEI # 3002524000 Luminex Corporation
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product...	2	11/10/2018	FEI # 3002524000 Luminex Corporation
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitativ...	2	09/30/2014	FEI # 3006028115 Nanosphere, Inc.
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-res...	2	09/23/2014	FEI # 3006028115 Nanosphere, Inc.