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Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
FDA product code CDT · Class 1 · Clinical Chemistry
115
Registered devices
96
Adverse events
20
Recalls
151
510(k) clearances
Devices with this code
JAS Diagnostics — DREW SCIENTIFIC, INC.Sirrus® Triglyceride LiquiColor® — STANBIO LABORATORY, L.P.Triglycerides — Roche Diagnostics GmbHNMR Reference Standard — Labcorp of AmericaCAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.AU — Beckman Coulter, Inc.Atellica CH Trig_2 — Siemens Healthcare Diagnostics Inc.ClearChem Diagnostics Inc. Triglycerides — CLEARCHEM DIAGNOSTICS INC.Triglyceride — HORIBA INSTRUMENTS INCORPORATEDJAS Diagnostics — DREW SCIENTIFIC, INC.CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT CC213 — CAROLINA LIQUID CHEMISTRIES CORPORATIONBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.TRIGLYCERIDE — SEKISUI DIAGNOSTICS, LLCIDG/Sanzay — IDG/SANZAY CorporationJAS Diagnostics — DREW SCIENTIFIC, INC.JAS Diagnostics — DREW SCIENTIFIC, INC.Pointe Triglyceride Reagent — HORIBA INSTRUMENTS INCORPORATEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.TRIGLYCERIDES (TRIGS) — RANDOX LABORATORIES LIMITEDPointe Scientific, Inc. Triglyceride — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT ST213 — 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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