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    This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·September 18, 2019

    Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.

    FDA Enforcement
    Class II ·Terminated·Response Biomedical Corp.·March 18, 2020

    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 3, 2018

    ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories·June 7, 2017

    Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·November 13, 2019

    Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories·March 21, 2018

    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories·March 21, 2018

    The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories·December 21, 2016

    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories·June 13, 2018

    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    Magnesium on RX Imola analyser IVD

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·December 14, 2016

    Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·May 16, 2018

    IgE Calibrator Series

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·October 12, 2016

    Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·October 26, 2016

    Liquid Cardiac Control CQ5053

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·March 21, 2018

    Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·August 8, 2018

    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018