34 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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
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
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 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
Fructosamine Control 3, FR2996 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
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·June 21, 2023
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
FDA Recall
Open, Classified
·Randox Laboratories·Product code DCK·February 1, 2023
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·July 19, 2023
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·November 20, 2023
RX Series Copper (Cu) Assay Ref. Number CU2340
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JKZ·November 29, 2023
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code OHQ·November 6, 2023
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·March 5, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIT·January 31, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code DDZ·January 31, 2024
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code CGA·September 6, 2023