FDA-Device2013-03-20Class III
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
Siemens Healthcare Diagnostics, Inc.
Hazard
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).
Sold states
Nationwide Distribution
Affected count
19, 503 cartons
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2013Don't want to check this manually?
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