Synchron
Direct LDL Cholesterol Reagent (LDLD 2 x 100)
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Guangxi (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | MRR |
| Device type | System, Test, Low Density, Lipoprotein |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2023-07-06 (version 3) |
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 |
|---|---|---|
| 969706 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 19 |
| Carolina Liquid Chemistries Corp.® LDL Cholesterol Direct Reagent KIT DT661 | Carolina Liquid Chemistries | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Direct LDL-Cholesterol (LDL) | Randox Laboratories Limited | 3 |
| Pointe autoLDL Cholesterol Reagent | Horiba Instruments Incorporated | 2 |
| N-geneous LDL-ST Cholesterol Reagent (R1) | Sekisui Diagnostics, LLC | 2 |
| Mercodia Oxidized LDL Elisa | Mercodia AB | 2 |
| ACE | Alfa Wassermann | 2 |
| N-geneous LDL-ST Cholesterol Reagent (R2) | Sekisui Diagnostics, LLC | 2 |
| Advia® Chemistry Direct LDL Cholesterol Reagents | Siemens Healthcare Diagnostics Inc | 1 |
| MedTest Dx, Inc. autoLDL | Medtest DX | 1 |
| Pointe Scientific, Inc. autoLDL Cholesterol | Horiba Instruments Incorporated | 1 |
Showing 12 of 26. All products under System, Test, Low Density, Lipoprotein
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K014103 | 2002-01-28 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2025-09-17 | Class II | Nonconforming Material/Component | Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August | 2,932 units | |
| 2003-08-15 | Not classified | Other | LDL Cholesterol component in controls are unstable. | 1780 all lots. | 2004-08-30 |
| 2003-02-10 | Not classified | Other | Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date. | 291 | 2004-12-02 |
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.