Nadh Oxidation/nad Reduction, Alt/sgpt
Clinical Chemistry · 21 CFR 862.1030
Recent MDR events
92 adverse event reports on file
- ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATIONApr 3, 2026MalfunctionRoche Diagnostics1823260-2026-01268
- ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATIONMar 13, 2026MalfunctionRoche Diagnostics1823260-2026-00913
- ALTP GEN.2Jan 12, 2026MalfunctionRoche Diagnostics1823260-2026-00141
- ALTP GEN.2Dec 29, 2025MalfunctionRoche Diagnostics1823260-2025-05349
- ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATIONDec 8, 2025MalfunctionRoche Diagnostics1823260-2025-04992
- ALANINE AMINOTRANSFERASENov 21, 2025MalfunctionRoche Diagnostics1823260-2025-04769
- ALTP GEN.2Oct 15, 2025MalfunctionRoche Diagnostics1823260-2025-04172
- ALTP GEN.2Jul 29, 2025MalfunctionRoche Diagnostics1823260-2025-02334
- ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATIONMay 30, 2025MalfunctionRoche Diagnostics1823260-2025-01674
- ALTP GEN.2May 2, 2025MalfunctionRoche Diagnostics1823260-2025-01361
Event type breakdown
Recalls
18 recall events for this product code
- Sterling Diagnostics, Inc.TerminatedDec 29, 2016
Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Z-0935-2017 · View FDA record ↗ - Alfa Wassermann, Inc.TerminatedApr 30, 2014
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent.
Extremely low absorbance readings.
Z-1529-2014 · View FDA record ↗ - Abaxis, IncorporatedTerminatedFeb 9, 2011
Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 40
Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer.
Z-1066-2011 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMay 22, 2008
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Z-1110-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMay 22, 2008
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Z-1111-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMay 22, 2008
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Z-1112-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMay 22, 2008
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Z-1113-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMay 22, 2008
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Z-1114-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMay 22, 2008
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Z-1115-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMay 22, 2008
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in
Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
Z-1116-2008 · View FDA record ↗
Registered firms
64 firms currently registered for this product code
Elhoda Trade And Supplies
Badr industerial city Al Qahirah, EG
Beckman Coulter, Inc.
CARLSBAD, CA, US
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Horiba Abx Sas
MONTPELLIER Herault, FR
Abbott Laboratories
Lake Forest, IL, US
Acro Biotech Inc.
Montclair, CA, US
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Diamond Diagnostics Inc.
Budapest, HU
Medicon Hellas Sa
GERAKAS Attiki, GR
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Mercedes Medical Llc
Lakewood Ranch, FL, US
Fisher Diagnostics
MIDDLETOWN, VA, US
Beckman Coulter, Inc.
BREA, CA, US
Carolina Liquid Chemistries
Brea, CA, US
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Alfa Wassermann
West Caldwell, NJ, US
High Technology, Inc.
North Attleboro, MA, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Cliniqa Corporation
San Marcos, CA, US
510(k) clearances
127 clearances for this product code
- Hitachi Chemical Diagnostics, Inc.Jun 7, 2013
K120945 · HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
- Alfa WassermannJul 19, 2012
K113382 · ACE ALT REAGENT
- Dade Behring, Inc.May 10, 2006
K061020 · DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
- Careside, Inc.Jun 4, 2002
K020487 · CARESIDE ALT
- Trace America, Inc.Feb 2, 1998
K980028 · ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- Trace America, Inc.Jan 7, 1998
K973869 · TRACE REAGENT LINE FOR THE COBAS MIRA
- Diagnostic Chemicals , Ltd.Dec 5, 1997
K974003 · ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
- Carolina Liquid Chemistries Corp.Apr 21, 1997
K971323 · ALT OR SGPT