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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 4 of 4 Results
510(K) Number: K062024
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Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers af... 2 06/13/2018 Siemens Healthcare Diagnostics, Inc.
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected... 2 06/13/2018 Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO m... 2 11/20/2012 Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro di... 2 03/21/2011 Siemens Healthcare Diagnostics, Inc.
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