FDA-Device2019-08-14Class II
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
Siemens Healthcare Diagnostics, Inc.
Hazard
Negative Bias with Lot EA9227.
Sold states
Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS MT NC NE NH NJ NY OK OR PR SD TN TX VA VT WA WI
Affected count
815 kits
Manufactured in
500 Gbc Dr, N/A, Newark, DE, United States
Products
Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2229-2019Don't want to check this manually?
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