120 results
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38ms
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Sources: EU EUDAMED, US FDA
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AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
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 Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·July 12, 2019
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·February 13, 2019
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJE·April 5, 2024
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 Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code LCP·June 7, 2017
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
FDA Recall
Open, Classified
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
FDA Recall
Open, Classified
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code NDY·February 14, 2024
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 Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code CDT·March 2, 2018
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code CEM·April 28, 2021
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JGJ·November 13, 2020
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJW·July 25, 2019
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JGJ·November 13, 2020
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·November 22, 2022
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·November 22, 2022
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 Recall
Terminated
·Randox Laboratories·Product code JJY·April 27, 2017
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·November 22, 2022
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJX·December 3, 2018
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIT·December 3, 2018