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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
K-ASSAY® UIBC Reagent — KAMIYA BIOMEDICAL COMPANY, LLCIRON (Fe) — RANDOX LABORATORIES LIMITEDUIBC-SL — Sekisui Diagnostics, LLCAtellica CH TIBC — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.K-ASSAY® UIBC Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCSynchron — Beckman Coulter, Inc.K-ASSAY® UIBC Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCSynermed® — INFRARED LABORATORY SYSTEMS LLCBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Synermed® — INFRARED LABORATORY SYSTEMS LLCDimension® Flex® reagent cartridge IBCT — Siemens Healthcare Diagnostics Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCSynchron — Beckman Coulter, Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDIron (Fe) Reagent Kit — MEDICA CORPORATIONSynermed® — INFRARED LABORATORY SYSTEMS LLCPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDTOTAL-IRON BINDING CAPACITY (TIBC) — RANDOX LABORATORIES LIMITEDADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge TIBC — Siemens Healthcare Diagnostics Inc.TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) — RANDOX LABORATORIES LIMITED
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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