Synchron
Uric Acid Reagent (URIC 2 x 300)
6manufacturers in China registered for this device type
1catalogue number
5recalls on this code
Who Else Makes It
Concentrated in Jilin (4), Shandong (1), Zhejiang (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 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | KNK |
| Device type | Acid, Uric, Uricase (Colorimetric) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1775 |
| 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 |
|---|---|---|
| 442785 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 18 |
| JAS Diagnostics | Drew Scientific, Ltd. | 9 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 7 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Carolina Liquid Chemistries Corp.® Uric Acid Reagent KIT AU-212 | Carolina Liquid Chemistries | 5 |
| Uric Acid ver.2 | Roche Diagnostics Gmbh | 4 |
| ONE+Step Uric Acid | DFI Co., Ltd. | 4 |
| AU | Beckman Coulter, Inc. | 4 |
| Pointe Scientific, Inc. Uric Acid | Horiba Instruments Incorporated | 3 |
| Uric Acid (UA) | Randox Laboratories Limited | 3 |
| Teco Diagnostics Uric Acid Liquid Reagent Set | Teco Diagnostics | 3 |
| ACE | Alfa Wassermann | 2 |
Showing 12 of 39. All products under Acid, Uric, Uricase (Colorimetric)
Recalls
5 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 | 16,983 reagents | 2024-02-28 |
| 2018-08-24 | Class II | Nonconforming Material/Component | NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. | 19,834 uits | 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. | 100,286 units total (20,732 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. | 59,401 units total (10,868 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 | 32,159 units total (10,462 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.