Brand

Randox Laboratories Ltd. Recalls

49 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Randox Laboratories Ltd..

49Total Recalls
0Critical
103,035Units Affected
Apr 5, 2024Most Recent
All Recalls

Every Randox Laboratories Ltd. Recall

Sorted by most recent. Click any recall for full details.

49 recalls
RecallFDA
Randox Laboratories Ltd.
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of dr...
Medical Devices·40 affected·Apr 5, 2024
High RiskFDA
Randox Laboratories Ltd.
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clin...
Medical Devices·80,366 affected·Mar 5, 2024
High RiskFDA
Randox Laboratories Ltd.
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog N...
Diagnostic Devices·666 affected·Feb 14, 2024
High RiskFDA
Randox Laboratories Ltd.
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Diagnostic Devices·8 affected·Jan 31, 2024
High RiskFDA
Randox Laboratories Ltd.
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Diagnostic Devices·6 affected·Jan 31, 2024
High RiskFDA
Randox Laboratories Ltd.
RX Series Copper (Cu) Assay Ref. Number CU2340
Diagnostic Devices·3,053 affected·Nov 29, 2023
High RiskFDA
Randox Laboratories Ltd.
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Diagnostic Devices·108 affected·Nov 20, 2023
High RiskFDA
Randox Laboratories Ltd.
Calibration Serum Level 3 CAL2351
Medical Devices·269 affected·Nov 20, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Medical Devices·0 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Medical Devices·13 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Medical Devices·35 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4,...
Diagnostic Devices·166 affected·Jul 19, 2023
High RiskFDA
Randox Laboratories Ltd.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Diagnostic Devices·37 affected·Jun 13, 2023
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of a...
Diagnostic Devices·1 affected·May 4, 2023
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducib...
Diagnostic Devices·30 affected·May 4, 2023
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immu...
Diagnostic Devices·115 affected·Nov 22, 2022
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems ...
Diagnostic Devices·146 affected·Nov 22, 2022
High RiskFDA
Randox Laboratories Ltd.
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Diagnostic Devices·20 affected·Nov 1, 2022
High RiskFDA
Randox Laboratories Ltd.
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
Diagnostic Devices·20 affected·Nov 1, 2022
High RiskFDA
Randox Laboratories Ltd.
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsA...
Medical Devices·2 affected·Aug 1, 2022
RecallFDA
Randox Laboratories Ltd.
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Medical Devices·12 affected·Jun 9, 2022
RecallFDA
Randox Laboratories Ltd.
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Medical Devices·12 affected·Jun 9, 2022
RecallFDA
Randox Laboratories Ltd.
CK MB Calibrator, Catalogue Number CK2393
Medical Devices·1,392 affected·Mar 25, 2022
High RiskFDA
Randox Laboratories Ltd.
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Medical Devices·15 affected·Nov 1, 2021
High RiskFDA
Randox Laboratories Ltd.
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Medical Devices·71 affected·May 10, 2021
High RiskFDA
Randox Laboratories Ltd.
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Medical Devices·50 affected·Apr 28, 2021
High RiskFDA
Randox Laboratories Ltd.
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Medical Devices·98 affected·Mar 29, 2021
High RiskFDA
Randox Laboratories Ltd.
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Medical Devices·1 affected·Nov 13, 2020
High RiskFDA
Randox Laboratories Ltd.
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of La...
Medical Devices·4 affected·Aug 11, 2020
High RiskFDA
Randox Laboratories Ltd.
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determinatio...
Medical Devices·21 affected·Aug 11, 2020
High RiskFDA
Randox Laboratories, Ltd.
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Diagnostic Devices·1,497 affected·Jul 10, 2020
High RiskFDA
Randox Laboratories Ltd.
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, i...
Diagnostic Devices·186 affected·Feb 18, 2020
RecallFDA
Randox Laboratories Ltd.
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Medical Devices·2 affected·Dec 13, 2019
High RiskFDA
Randox Laboratories Ltd.
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are ...
Diagnostic Devices·100 affected·Aug 9, 2019
RecallFDA
Randox Laboratories Ltd.
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality c...
Diagnostic Devices·1 affected·Jul 25, 2019
High RiskFDA
Randox Laboratories Ltd.
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic u...
Diabetes Devices·10 affected·Apr 3, 2019
High RiskFDA
Randox Laboratories Ltd.
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Cardiac Devices·11,420 affected·Mar 11, 2019
RecallFDA
Randox Laboratories Ltd.
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as ass...
Diagnostic Devices·4 affected·Feb 7, 2019
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as...
Diagnostic Devices·58 affected·Feb 7, 2019
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic us...
Diagnostic Devices·12 affected·Feb 7, 2019
High RiskFDA
Randox Laboratories Ltd.
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Diagnostic Devices·225 affected·Dec 4, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·133 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·85 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·141 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprot...
Diagnostic Devices·250 affected·Nov 19, 2018
High RiskFDA
Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5053
Cardiac Devices·2,108 affected·Oct 2, 2018
High RiskFDA
Randox Laboratories Ltd.
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Diagnostic Devices·0 affected·May 22, 2018
High RiskFDA
Randox Laboratories Ltd.
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional...
Medical Devices·8 affected·Mar 2, 2018