Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantit

Recalled November 14, 2012 · FDA recall Z-0253-2013 · Siemens Healthcare Diagnostics

Hazard

Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. · FDA Class III

Units

583 cartons

Sold at

USA (nationwide) including the states of AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.

Description

Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.

Product

Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) 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 →