Phosphomolybdate (colorimetric), Inorganic Phosphorus
Clinical Chemistry · 21 CFR 862.1580
Recent MDR events
113 adverse event reports on file
- PHOSPHATE (INORGANIC) VER.2Jul 16, 2026MalfunctionRoche Diagnostics1823260-2026-02890
- PHOSPHATE (INORGANIC) VER.2Dec 4, 2025MalfunctionRoche Diagnostics1823260-2025-04942
- PHOSPHATE (INORGANIC) VER.2Dec 3, 2025MalfunctionRoche Diagnostics1823260-2025-04930
- ATELLICA CH INORGANIC PHOSPHORUS (IP) (5100T)Nov 20, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2025-00296
- PHOSPHATE (INORGANIC) VER.2Nov 10, 2025MalfunctionRoche Diagnostics1823260-2025-04571
- PHOSPHATE (INORGANIC) VER.2Oct 28, 2025MalfunctionRoche Diagnostics1823260-2025-04387
- ALINITY C PHOSPHORUS2Sep 10, 2025MalfunctionAbbott Ireland Diagnostics Division3005094123-2025-00441
- PHOSPHATE (INORGANIC) VER.2May 29, 2025MalfunctionRoche Diagnostics1823260-2025-01638
- DIMENSION PHOSPHORUS FLEX REAGENT CARTRIDGEJan 27, 2025MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2025-00014
- PHOS2Dec 19, 2024MalfunctionRoche Diagnostics1823260-2024-03752
Event type breakdown
Recalls
8 recall events for this product code
- Beckman Coulter Inc.Open, ClassifiedOct 8, 2025
SYNCHRON Systems Phosphorus (PHOSm) Reagent
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Z-0071-2026 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedMay 27, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL 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-1832-2025 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedNov 15, 2013
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Z-0320-2014 · View FDA record ↗ - Abbott Laboratories, IncTerminatedOct 17, 2013
Clinical Chemistry Phosphorus Reagent
Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
Z-0020-2014 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedApr 2, 2013
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)
Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.
Z-1049-2013 · View FDA record ↗ - Alfa Wassermann, Inc.TerminatedJan 28, 2013
Alfa Wassermann System Diluent 750 mL
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Z-0743-2013 · View FDA record ↗ - Abbott Laboratories Inc.TerminatedSep 10, 2010
Clinical Chemistry Phosphorus assay
Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
Z-2398-2010 · View FDA record ↗ - Abbott Laboratories Inc.TerminatedApr 5, 2007
Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)
Z-0722-2007 · View FDA record ↗
Registered firms
64 firms currently registered for this product code
Carolina Liquid Chemistries
Brea, CA, US
Hemagen Diagnostics, Inc.
Baltimore, MD, US
Horiba Instruments Incorporated
Canton, MI, US
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Alfa Wassermann
West Caldwell, NJ, US
Infrared Laboratory Systems Dba Synermed
WESTFIELD, IN, 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
Abbott Laboratories
Irving, TX, US
Beckman Coulter, Inc.
BREA, CA, US
Diamond Diagnostics Inc.
Budapest, HU
Abaxis, Inc.
UNION CITY, CA, US
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Ortho-clinical Diagnostics, Inc.
ROCHESTER, NY, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Fisher Diagnostics
MIDDLETOWN, VA, US
510(k) clearances
105 clearances for this product code
- Seppim S.A.S.May 6, 2011
K100263 · ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
- Alfa Wassermann Diagnostic Technologies, Inc.Jun 24, 2008
K072141 · S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
- Beckman Coulter, Inc.Aug 18, 2004
K041643 · SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
- Elan DiagnosticsMar 7, 2003
K030015 · ATAC PAK PHOSPHORUS REAGENT
- Abaxis, Inc.Sep 5, 2002
K022312 · PICCOLO PHOSPHORUS TEST SYSTEM
- Wiener Laboratories SaicNov 16, 2001
K013095 · WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
- Jas Diagnostics, Inc.Feb 21, 2001
K003912 · PHOSPHORUS REAGENT
- Hemagen Diagnostics, Inc.Oct 25, 2000
K003012 · RAICHEM PHOSPORUS REAGENT