Synchron
Triglycerides Reagent (TG 2 x 300)
2manufacturers in China registered for this device type
1catalogue number
6recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | CDT |
| Device type | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1705 |
| 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 |
|---|---|---|
| 445850 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 20 |
| JAS Diagnostics | Drew Scientific, Ltd. | 8 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 7 |
| Synermed® | Infrared Laboratory Systems LLC | 6 |
| AU | Beckman Coulter, Inc. | 5 |
| Triglycerides | Roche Diagnostics Gmbh | 4 |
| Triglycerides (Trigs) | Randox Laboratories Limited | 4 |
| Carolina Liquid Chemistries Corp.® Triglycerides Reagent KIT DT213 | Carolina Liquid Chemistries | 4 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 3 |
| Teco Diagnostics Triglyceride – GPO Liquid Reagent Set | Teco Diagnostics | 3 |
| Triglycerides/Glycerol Blanked | Roche Diagnostics Gmbh | 2 |
| Triglyceride-SL | Sekisui Diagnostics, LLC | 2 |
Showing 12 of 48. All products under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Recalls
6 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 |
|---|---|---|---|---|---|
| 2019-08-15 | Class II | Device Design | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could res | 2024-02-28 | |
| 2018-08-24 | Class II | Nonconforming Material/Component | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. | 20,926 units | 2024-08-02 |
| 2017-04-03 | Class II | Under Investigation by firm | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results. | 124,068 units total (47,920 units in US) | 2018-05-31 |
| 2016-04-13 | Class II | Device Design | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. | 32,926 units total (6,041 units in US) | 2016-06-30 |
| 2016-04-13 | Class II | Device Design | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. | 79,009 units total (21,215 units in US) | 2016-06-30 |
| 2014-12-15 | Class II | Under Investigation by firm | N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30 | 75,959 units total (31,233 units in US) | 2016-02-19 |
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.