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Ferrozine (Colorimetric) Iron Binding Capacity
FDA product code JMO · Class 1 · Clinical Chemistry
51
Registered devices
0
Adverse events
7
Recalls
46
510(k) clearances
Devices with this code
UIBC-SL — SEKISUI DIAGNOSTICS, LLCUIBC — RANDOX LABORATORIES LIMITEDK-ASSAY® UIBC Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCACE — ALFA WASSERMANN, INC.Fe — RANDOX LABORATORIES LIMITEDIRON (Fe) — RANDOX LABORATORIES LIMITEDUnsaturated Iron-Binding Capacity — Roche Diagnostics GmbHTOTAL IRON-BINDING CAPACITY 2 (TIBC_2) — RANDOX LABORATORIES LIMITEDIRON (Total) — SEKISUI DIAGNOSTICS, LLCADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents — Siemens Healthcare Diagnostics Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDUIBC-SL — SEKISUI DIAGNOSTICS, LLCSynermed® — INFRARED LABORATORY SYSTEMS LLCK-ASSAY® UIBC Reagent — KAMIYA BIOMEDICAL COMPANY, LLCUIBC-SL — SEKISUI DIAGNOSTICS, LLCSynchron — Beckman Coulter, Inc.IRON (Total) — SEKISUI DIAGNOSTICS, LLCK-ASSAY® UIBC Reagent — KAMIYA BIOMEDICAL COMPANY, LLCBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) — RANDOX LABORATORIES LIMITEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDAtellica CH TIBC — Siemens Healthcare Diagnostics Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Dimension® Flex® reagent cartridge IBCT — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-26 | Beckman Coulter Inc. | Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant |
| 2024-05-14 | Ortho-Clinical Diagnostics, Inc. | Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expirati |
| 2020-08-18 | Beckman Coulter Inc. | 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 o |
| 2016-05-24 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confir |
| 2012-12-20 | Siemens Healthcare Diagnostics, Inc. | The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid.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 act |
| 2009-12-16 | Siemens Healthcare Diagnostics, Inc. | Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples. |
| 2008-03-14 | Diagnostic Chemicals, Ltd. | Precipitate in product may cause elevated background absorbance interference. |
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