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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K081643
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The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diag... 2 11/24/2010 Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges 2 10/19/2011 Siemens Healthcare Diagnostics, Inc.
Dimension Vista® CTNI Sample Diluent, KD692, SMN# 10445205 2 07/13/2018 Siemens Healthcare Diagnostics, Inc.
Dimension Troponin 1 (TNI) Flex reagent cartridge 2 05/05/2017 Siemens Healthcare Diagnostics, Inc.
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