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Sources: EU EUDAMED, US FDA
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Country: Ireland
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Metaphysis (Ireland) Ltd
Authorized representative
🇮🇪 Ireland·1 Manufacturer·4 Devices
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 24, 2024
Cook Ireland
Importer
🇮🇪 Ireland·3 Manufacturers
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 Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·October 2, 2019
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·July 28, 2021
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·December 8, 2021
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·December 16, 2020
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·December 16, 2020
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·February 12, 2020
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 24, 2024
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 Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 11, 2023
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 Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 11, 2023
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 Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·January 11, 2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·July 5, 2023
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
FDA Enforcement
Class II
·Ongoing·Randox Laboratories Ltd.·March 27, 2024
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·July 5, 2023
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 28, 2022
Cook Medical Europe Ltd
Importer
🇮🇪 Ireland·9 Manufacturers
International Associates Auditing & Certification Limited
Authorized representative
🇮🇪 Ireland·46 Manufacturers·161 Devices