26 results
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27ms
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Sources: EU EUDAMED, US FDA
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Country: Ireland
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AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
FDA Enforcement
Class I
·Terminated·Armstrong Medical Services Limited·September 22, 2021
ASAP Innovations Ltd.
Importer
🇮🇪 Ireland·1 Manufacturer
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
LTC Healthcare Europe Limited
Importer
🇮🇪 Ireland·2 Manufacturers
Alinity i Estradiol Reagent Kit, List Number 07P5020
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·May 19, 2021
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Progesterone Reagent Kit, List Number 08P3620
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Alinity i TSH Reagent Kit, List Number 07P4830
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Trasmore Ltd T/A Dental Medical Ireland
Importer
🇮🇪 Ireland·7 Manufacturers
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·December 14, 2022
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·December 14, 2022
Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·August 14, 2019
Teleflex Medical
Importer
🇮🇪 Ireland·15 Manufacturers
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 23, 2020
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·September 23, 2020
Multichem P, Part Code 08P90-10
FDA Enforcement
Class II
·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023