Home / Recalls / Medical Devices
Siemens Healthcare Diagnostics, Inc. recalls Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantita
Recalled March 20, 2013 · FDA recall Z-0933-2013 · Siemens Healthcare Diagnostics
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The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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). · FDA Class III
Units
19, 503 cartons
Sold at
Nationwide Distribution
Description
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →