Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1050
Recent MDR events
74 adverse event reports on file
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Jul 22, 2026MalfunctionRoche Diagnostics1823260-2026-02978
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Jun 18, 2026MalfunctionRoche Diagnostics1823260-2026-02434
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2May 28, 2026MalfunctionRoche Diagnostics1823260-2026-02107
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Feb 11, 2026MalfunctionRoche Diagnostics1823260-2026-00477
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Jan 9, 2026MalfunctionRoche Diagnostics1823260-2026-00121
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Nov 26, 2025MalfunctionRoche Diagnostics1823260-2025-04867
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Nov 17, 2025MalfunctionRoche Diagnostics1823260-2025-04671
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Oct 6, 2025MalfunctionRoche Diagnostics1823260-2025-04069
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Sep 24, 2025MalfunctionRoche Diagnostics1823260-2025-03583
- ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2Sep 8, 2025MalfunctionRoche Diagnostics1823260-2025-02783
Event type breakdown
Recalls
22 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedMay 27, 2025
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1835-2025 · View FDA record ↗ - Ortho-Clinical Diagnostics, INc.Open, ClassifiedSep 21, 2023
VITROS XT Chemistry Products ALKP Slides
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
Z-2624-2023 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedNov 15, 2013
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Z-0296-2014 · View FDA record ↗ - Abbott Laboratories, IncTerminatedSep 26, 2011
Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31.
The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.
Z-3278-2011 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMar 27, 2008
Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the quantitative determ
May be contaminated with microorganisms.
Z-1353-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMar 27, 2008
Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum,
May be contaminated with microorganisms.
Z-1354-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMar 27, 2008
Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.
May be contaminated with microorganisms.
Z-1355-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMar 27, 2008
Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Scientific.
May be contaminated with microorganisms.
Z-1356-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMar 27, 2008
Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Scientific
May be contaminated with microorganisms.
Z-1357-2008 · View FDA record ↗ - Pointe Scientific, Inc.TerminatedMar 27, 2008
Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120
May be contaminated with microorganisms.
Z-1358-2008 · View FDA record ↗
Registered firms
61 firms currently registered for this product code
Cliniqa Corporation
San Marcos, CA, US
Teco Diagnostics
ANAHEIM, CA, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Abbott Ireland Diagnostics Division
Longford, IE
Horiba Instruments Incorporated
Canton, MI, US
Vitalscientific
SEES Normandie, FR
Beckman Coulter, Inc.
CARLSBAD, CA, US
Sebia
EVRY Essonne, FR
Infrared Laboratory Systems Dba Synermed
WESTFIELD, IN, US
Abbott Laboratories
Lake Forest, IL, US
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
High Technology, Inc.
North Attleboro, MA, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Diamond Diagnostics Inc.
Budapest, HU
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Ortho-clinical Diagnostics, Inc.
ROCHESTER, NY, US
Stanbio Laboratory
Boerne, TX, US
Fisher Diagnostics
MIDDLETOWN, VA, US
510(k) clearances
124 clearances for this product code
- Truvian HealthDec 19, 2025
K251074 · Tru Liver Health Test Panel
- Abbott Laboratories Diagnostics DivisionOct 16, 2024
K240468 · Alkaline Phosphatase
- Abbott Ireland Diagnostics DivisionJul 21, 2023
K223317 · Alkaline Phosphatase2
- HORIBA ABX SASAug 30, 2019
K191245 · Yumizen C1200 ALP, Yumizen C1200 Albumin
- Lite-On Technology Corp. H.S.P.B.Jan 25, 2018
K171971 · Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
- Roche Diagnostics Operations (Rdo)May 10, 2017
K171080 · ALP IFCC Gen.2
- Randox Laboratories LimitedApr 21, 2017
K162275 · Randox RX Daytona Plus Alkaline Phosphatase (ALP)
- Alfa Wassermann Diagnostic Technologies, LLCAug 15, 2013
K131351 · ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT