Ferrozine (colorimetric) Iron Binding Capacity
Siemens Healthcare Diagnostics Inc.'s record for this product code
MDR events0All time
Recalls2All time
510(k) clearances0All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for Siemens Healthcare Diagnostics Inc. under this product code.
Recalls
2 recall events for this product code
- TerminatedMar 11, 2013
The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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).
View FDA record ↗ - TerminatedSep 8, 2010
Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Siemens Healthcare Diagnostics Inc. under this product code.