Device 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.
Z-0541-2014
Product summary
- Event
- Event 66363
- Status
- Terminated
- Classification
- Class II
- Quantity
- 302
- Official record key
device-enforcement:Z-0541-2014
Official wording
Reason: Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
Code information: lot 13064MA, expiration 2014-03-05
Distribution pattern: 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.
Derived failure modes
-
Unknown
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.