Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the qu

Recalled December 25, 2013 · FDA recall Z-0541-2014 · Siemens Healthcare Diagnostics

Hazard

Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. · FDA Class II

Units

302

Sold at

Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.

Description

Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

Product

Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →