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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 32 Results
510(K) Number: K051087
 
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Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures s... 2 12/02/2021 Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures s... 2 12/02/2021 Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, Analyzer, chemistry Model no. 10284473 2 03/15/2019 Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual a... 2 12/14/2018 Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer... 2 03/19/2017 Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, De... 2 06/01/2016 Siemens Healthcare Diagnostics Inc.
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Dev... 2 06/01/2016 Siemens Healthcare Diagnostics Inc.
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro di... 2 05/06/2016 Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent La... 2 07/09/2015 Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in... 2 12/20/2014 Siemens Healthcare Diagnostics, Inc.
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