Dimension® Flex® Reagent Cartridge Trig
Triglycerides Flex® reagent cartridge, 480 tests
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
8recalls 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 | Siemens Healthcare Diagnostics 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K010871 |
| Record published | 2020-09-24 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10444906 | 4 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133067 | 2013-11-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-03-17 | Class II | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn | 137422 units total | 2017-09-25 |
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 |
|---|---|---|---|---|---|
| 2023-01-27 | Class II | Under Investigation by firm | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results | 11824 units | |
| 2023-01-27 | Class II | Under Investigation by firm | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results | 5315 units | |
| 2021-10-06 | Class II | Software design | The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and c | 1142 | |
| 2016-03-17 | Class II | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn | 137422 units total | 2017-09-25 |
| 2016-03-17 | Class II | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn | 137422 units total | 2017-09-25 |
| 2016-03-07 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life f | 7,433 units (4,228 for lot 348297 and 3,199 for lot # 359932 | 2017-12-01 |
| 2009-09-01 | Not classified | Software design | Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus v | 81 units | 2010-09-15 |
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.