Device 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.
Z-0253-2013
Product summary
- Event
- Event 62833
- Status
- Terminated
- Classification
- Class III
- Quantity
- 583 cartons
- Official record key
device-enforcement:Z-0253-2013
Official wording
Reason: Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
Code information: Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012
Distribution pattern: 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.
Derived failure modes
-
Unknown
Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.