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Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
FDA product code CDT · Class 1 · Clinical Chemistry
115
Registered devices
101
Adverse events
20
Recalls
151
510(k) clearances
Devices with this code
JAS Diagnostics — DREW SCIENTIFIC, INC.TRIG Reagent Kit — MEDICA CORPORATIONTRIGLYCERIDE — Sekisui Diagnostics, LLCPointe Scientific, Inc. Triglycerides — HORIBA INSTRUMENTS INCORPORATEDAlinity — Abbott GmbHTriglycerides — Roche Diagnostics GmbHTRIGLYCERIDES (TRIGS) — RANDOX LABORATORIES LIMITEDTriglycerides — Roche Diagnostics GmbHPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDTeco Diagnostics Triglyceride - GPO Liquid Reagent Set — TECO DIAGNOSTICSTriglycerides — Roche Diagnostics GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Synermed® — INFRARED LABORATORY SYSTEMS LLCADVIA® Chemistry TRIG_c Reagent — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT DT213 — CAROLINA LIQUID CHEMISTRIES CORPORATIONTeco Diagnostics Triglyceride Reagent Kit TC-Matrix — TECO DIAGNOSTICSTeco Diagnostics Triglyceride - GPO Liquid Reagent Set — TECO DIAGNOSTICSPTS Panels® Triglycerides Test Strips — POLYMER TECHNOLOGY SYSTEMS, INC.NMR Diluent 1 — Labcorp of AmericaAtellica CH Trig_2 — Siemens Healthcare Diagnostics Inc.Triglyceride — HORIBA INSTRUMENTS INCORPORATEDPrecimat Glycerol — Roche Diagnostics GmbHAU — Beckman Coulter, Inc.CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213 — CAROLINA LIQUID CHEMISTRIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-27 | Siemens Healthcare Diagnostics, Inc. | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2023-01-27 | Siemens Healthcare Diagnostics, Inc. | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2021-10-06 | Siemens Healthcare Diagnostics, Inc. | 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. I |
| 2019-08-15 | Beckman Coulter Inc | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if pr |
| 2018-08-24 | Beckman Coulter Inc. | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. |
| 2018-03-02 | Randox Laboratories Ltd. | Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments. |
| 2017-04-03 | Beckman Coulter Inc. | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result |
| 2016-08-11 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplemen |
| 2016-08-02 | Randox Laboratories Ltd. | According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to |
| 2016-04-13 | Beckman Coulter Inc. | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6 |
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