Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Clinical Chemistry · 21 CFR 862.1440
Recent MDR events
113 adverse event reports on file
- LACTATE DEHYDROGENASE ACC. IFCC VER.2Jul 1, 2026MalfunctionRoche Diagnostics1823260-2026-02645
- LACTATE DEHYDROGENASE ACC. IFCC VER.2May 7, 2026MalfunctionRoche Diagnostics1823260-2026-01791
- LACTATE DEHYDROGENASE ACC. IFCC VER.2Feb 23, 2026MalfunctionRoche Diagnostics1823260-2026-00643
- LACTATE DEHYDROGENASE ACC. IFCC VER.2Feb 11, 2026MalfunctionRoche Diagnostics1823260-2026-00483
- LACTATE DEHYDROGENASE ACC. IFCC VER.2Jan 26, 2026MalfunctionRoche Diagnostics1823260-2026-00265
- LACTATE DEHYDROGENASE ACC. IFCC VER.2Dec 23, 2025MalfunctionRoche Diagnostics1823260-2025-05328
- LACTATE DEHYDROGENASE ACC. IFCC VER.2Dec 19, 2025MalfunctionRoche Diagnostics1823260-2025-05247
- LACTATE DEHYDROGENASEDec 17, 2025MalfunctionRoche Diagnostics1823260-2025-05167
- LACTATE DEHYDROGENASE ACC. IFCC VER.2Dec 8, 2025MalfunctionRoche Diagnostics1823260-2025-04987
- LACTATE DEHYDROGENASENov 26, 2025MalfunctionRoche Diagnostics1823260-2025-04866
Event type breakdown
Recalls
8 recall events for this product code
- Medtest Holdings, Inc.TerminatedMay 26, 2017
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.
Z-2165-2017 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedJun 27, 2015
Lactate.
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-1926-2015 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedNov 15, 2013
VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Z-0315-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in hum
Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to determine the etiology of tissue damage. Results would be correlated with clinical history and presentation in addition to other diagnostic laboratory testing.
Z-0499-2019 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedUnknown
Advia Chemistry Assay: Lactate
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 from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
Z-1656-2016 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
Lactate Reagent (LACT 2 x 50), Catalog No. A95550
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Z-2078-2017 · View FDA record ↗ - Randox Laboratories Ltd.TerminatedUnknown
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogen
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.
Z-2962-2020 · View FDA record ↗ - Randox Laboratories Ltd.TerminatedUnknown
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.
Z-2963-2020 · View FDA record ↗
Registered firms
62 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
Sanzay Corporation -
Miami Gardens, FL, US
Infrared Laboratory Systems Dba Synermed
WESTFIELD, IN, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Beckman Coulter, Inc.
BREA, CA, US
Carolina Liquid Chemistries
Brea, CA, US
Teco Diagnostics
ANAHEIM, CA, US
Abbott Gmbh
Wiesbaden Hesse, DE
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Cliniqa Corporation
San Marcos, CA, US
Medicon Hellas Sa
GERAKAS Attiki, GR
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Abaxis, Inc.
UNION CITY, CA, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Alfa Wassermann
West Caldwell, NJ, US
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Fisher Diagnostics
MIDDLETOWN, VA, US
Mercedes Medical Llc
Lakewood Ranch, FL, US
Ortho Clinical Diagnostics
Singapore South West, SG
510(k) clearances
111 clearances for this product code
- Alfa Wassermann Diagnostic Technologies, Inc.Oct 2, 2013
K131975 · ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
- Alfa Wassermann, Inc.Sep 9, 2009
K091544 · S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
- Abaxis, Inc.Jul 8, 2005
K051108 · PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
- Diagnostic Chemicals , Ltd.Jan 22, 1998
K974859 · LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
- Pointe Scientific, Inc.,Oct 8, 1997
K973589 · LIQUID LDH-L REAGENT SET
- Randox Laboratories, Ltd.May 7, 1997
K970684 · LACTATE DEHYDROGENASE (LD)
- Carolina Liquid Chemistries Corp.May 2, 1997
K971398 · LD-L REAGENT
- Derma Media Lab., Inc.Jan 9, 1997
K964912 · LACTATE DEHYDROGENASE