Synchron
SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit
2manufacturers in China registered for this device type
3catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JMO |
| Device type | Ferrozine (Colorimetric) Iron Binding Capacity |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1415 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2023-08-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 465976 | In distribution | |
| 465971 | In distribution | |
| 467910 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synermed® | Infrared Laboratory Systems LLC | 5 |
| Fe | Randox Laboratories Limited | 4 |
| Uibc-SL | Sekisui Diagnostics, LLC | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 3 |
| Total Iron-Binding Capacity 2 (TIBC_2) | Randox Laboratories Limited | 3 |
| Iron (Total) | Sekisui Diagnostics, LLC | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| K-Assay® Uibc Reagent | Kamiya Biomedical Company LLC | 2 |
| Total-Iron Binding Capacity (Tibc) | Randox Laboratories Limited | 2 |
| Iron (Fe) | Randox Laboratories Limited | 2 |
| Direct Tibc Reagent | Medtest DX | 1 |
| AU | Beckman Coulter, Inc. | 1 |
Showing 12 of 29. All products under Ferrozine (Colorimetric) Iron Binding Capacity
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-06-26 | Class II | Process design | 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 t | 56,696 units | |
| 2020-08-18 | Class II | Under Investigation by firm | 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. | 219 units | 2021-09-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.