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Sources: EU EUDAMED, US FDA
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WE ARE RILEY LTD
FDA registration
WE ARE RILEY LTD·2 products·🇮🇪 Ireland
Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.
FDA Enforcement
Class II
·Terminated·Merck Millipore Ltd.·November 28, 2018
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
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
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
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
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 Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·April 3, 2019
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
FDA Enforcement
Class II
·Ongoing·THERAKOS DEVELOPMENT LIMITED·April 22, 2026
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·November 13, 2019
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