Randox Laboratories Ltd.
51 recalls on record · Latest: May 15, 2024
FDA Devices Low May 15, 2024
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human…
FDA Devices Moderate May 15, 2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemist…
FDA Devices Moderate Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
FDA Devices Moderate Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
FDA Devices Moderate Apr 3, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2…
FDA Devices Moderate Feb 14, 2024
RX Series Copper (Cu) Assay Ref. Number CU2340
FDA Devices Moderate Jan 24, 2024
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Devices Moderate Jan 24, 2024
Calibration Serum Level 3 CAL2351
FDA Devices Moderate Nov 8, 2023
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
FDA Devices Moderate Nov 8, 2023
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
FDA Devices Moderate Nov 8, 2023
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
FDA Devices Moderate Aug 30, 2023
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferrit…
FDA Devices Moderate Aug 16, 2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
FDA Devices Low Jul 5, 2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Ca…
FDA Devices Low Jul 5, 2023
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of ana…
FDA Devices Moderate Jan 11, 2023
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay syst…
FDA Devices Moderate Jan 11, 2023
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Numb…
FDA Devices Moderate Dec 14, 2022
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
FDA Devices Moderate Dec 14, 2022
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
FDA Devices Moderate Sep 28, 2022
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,…
FDA Devices Low Jul 27, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
FDA Devices Low Jul 27, 2022
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
FDA Devices Low May 25, 2022
CK MB Calibrator, Catalogue Number CK2393
FDA Devices Moderate Dec 8, 2021
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
FDA Devices Moderate Jul 28, 2021
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Devices Moderate Jul 14, 2021
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
FDA Devices Moderate May 19, 2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
FDA Devices Moderate Dec 16, 2020
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
FDA Devices Moderate Sep 23, 2020
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydr…
FDA Devices Moderate Sep 23, 2020
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate…
FDA Devices Moderate Sep 23, 2020
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Devices Moderate Sep 9, 2020
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Devices Moderate Aug 12, 2020
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determ…
FDA Devices Moderate Apr 1, 2020
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the qualit…
FDA Devices Low Feb 12, 2020
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Devices Moderate Nov 13, 2019
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for…
FDA Devices Low Oct 2, 2019
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of ur…
FDA Devices Moderate Jun 26, 2019
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
FDA Devices Moderate May 8, 2019
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the q…
FDA Devices Low Apr 17, 2019
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality…
FDA Devices Low Apr 17, 2019
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed qua…
FDA Devices Low Apr 17, 2019
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assaye…
FDA Devices Moderate Mar 27, 2019
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…
FDA Devices Moderate Mar 27, 2019
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…
FDA Devices Moderate Mar 27, 2019
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…
FDA Devices Moderate Feb 27, 2019
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
FDA Devices Moderate Jan 2, 2019
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, Ig…
FDA Devices Moderate Nov 14, 2018
Liquid Cardiac Control, CQ5053
FDA Devices Moderate Jul 4, 2018
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
FDA Devices Moderate May 16, 2018