03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system. [Code Info] lot 12095AD, exp 2013-04-04 [Reason for Recall] Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification] 
Class III
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Enforcement Report - Week of August 15, 2012