Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Clinical Chemistry · 21 CFR 862.1705
Recent MDR events
96 adverse event reports on file
- TRIGLYCERIDESJul 21, 2026MalfunctionRoche Diagnostics1823260-2026-02944
- TRIGLYCERIDESJul 16, 2026MalfunctionRoche Diagnostics1823260-2026-02887
- TRIGLYCERIDESJun 23, 2026MalfunctionRoche Diagnostics1823260-2026-02487
- TRIGLYCERIDESJun 17, 2026MalfunctionRoche Diagnostics1823260-2026-02391
- TRIGLYCERIDESJun 15, 2026MalfunctionRoche Diagnostics1823260-2026-02361
- TRIGLYCERIDESJun 10, 2026MalfunctionRoche Diagnostics1823260-2026-02278
- TRIGLYCERIDESJun 8, 2026MalfunctionRoche Diagnostics1823260-2026-02239
- TRIGLYCERIDESMay 27, 2026MalfunctionRoche Diagnostics1823260-2026-02079
- TRIGLYCERIDESMay 19, 2026MalfunctionRoche Diagnostics1823260-2026-01960
- TRIGLYCERIDESMay 18, 2026MalfunctionRoche Diagnostics1823260-2026-01933
Event type breakdown
Recalls
20 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.Open, ClassifiedAug 29, 2023
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Z-1270-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedAug 29, 2023
Atellica CH Triglycerides_2: in vitro diagnostic use in the
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Z-1271-2023 · View FDA record ↗ - Randox Laboratories Ltd.TerminatedOct 18, 2016
Randox Lipase (Colorimetric)
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 amend the running order for all instruments using these reagents to ensure Lipase is not place directly before or after LDL or Triglycerides. A correction was made to the IFU for the Lipase assay and all customers who purchased the Lipase kit in the USA were contacted with the updated instruction.
Z-0123-2017 · View FDA record ↗ - Horiba Instruments IncTerminatedFeb 2, 2016
ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based o
N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.
Z-0742-2016 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedJun 27, 2015
Triglycerides/Glycerol Blanked.
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Z-1930-2015 · View FDA record ↗ - Beckman Coulter Inc.TerminatedJan 28, 2015
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
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. NAC interference may lead to falsely low results.
Z-1023-2015 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedDec 22, 2014
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Z-0848-2015 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedMar 24, 2010
Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analyti
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 volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.
Z-1205-2010 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedUnknown
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.
Z-0091-2017 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedUnknown
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
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 clinical decisions.
Z-0193-2022 · View FDA record ↗
Registered firms
80 firms currently registered for this product code
Diamond Diagnostics Inc.
Budapest, HU
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Sanzay Corporation -
Miami Gardens, FL, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Ortho Clinical Diagnostics
Singapore South West, SG
Horiba Instruments Incorporated
Canton, MI, US
Beckman Coulter, Inc.
BREA, CA, US
Carolina Liquid Chemistries
Brea, CA, US
Medica Corp.
BEDFORD, MA, US
Abbott Laboratories
Lake Forest, IL, US
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Teco Diagnostics
ANAHEIM, CA, US
Mercedes Medical Llc
Lakewood Ranch, FL, US
Medicon Hellas Sa
GERAKAS Attiki, GR
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
510(k) clearances
151 clearances for this product code
- Randox Laboratories LimitedAug 6, 2015
K150819 · Triglycerides
- Siemens Healthcare Diagnostics, Inc.Nov 22, 2013
K133067 · ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
- Ortho-Clinical Diagnostics, Inc.May 31, 2013
K130332 · VITROS CHEMISTRY PRODUCTS TRIG SLIDES
- LiposcienceAug 30, 2012
K113830 · VANTERA CLINICAL ANALYZER
- Seppim S.A.S.May 19, 2011
K102993 · ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
- Olympus America, Inc.Mar 23, 2007
K063804 · OLYMPUS TRIGLYCERIDE TEST SYSTEM
- Dade Behring, Inc.Jan 18, 2005
K043546 · DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
- Clinical Data, Inc.Mar 10, 2004
K034000 · VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR