Ferrozine (colorimetric) Iron Binding Capacity
Beckman Coulter, Inc.'s record for this product code
Recent MDR events
0 adverse event reports on file
No MDR events on file for Beckman Coulter, Inc. under this product code.
Recalls
2 recall events for this product code
- Open, ClassifiedAug 4, 2025
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
View FDA record ↗ - TerminatedUnknown
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Beckman Coulter, Inc. under this product code.