Home / Companies / Randox Laboratories Ltd.

Randox Laboratories Ltd.

FDA Regulatory Profile

Summary

Total Recalls
85
510(k) Clearances
116
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2425-2024Class IIRX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C June 7, 2024
Z-1786-2024Class IIIEvidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parenApril 5, 2024
Z-1759-2024Class IIClinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human basedMarch 5, 2024
Z-1328-2024Class IILiquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG,March 1, 2024
Z-1369-2024Class IICystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C asFebruary 14, 2024
Z-1593-2024Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog NumbJanuary 31, 2024
Z-1594-2024Class IIMicroalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MJanuary 31, 2024
Z-0992-2024Class IIRX Series Copper (Cu) Assay Ref. Number CU2340November 29, 2023
Z-0752-2024Class IICalibration Serum Level 3 CAL2351November 20, 2023
Z-0753-2024Class IICalibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog NumberNovember 20, 2023
Z-0751-2024Class IICalibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human AssayNovember 13, 2023
Z-0624-2024Class IIISEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination ofNovember 6, 2023
Z-0501-2024Class IIRANDOX Total Bilirubin.October 11, 2023
Z-0200-2024Class IIRX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)September 6, 2023
Z-0201-2024Class IIRX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000September 6, 2023
Z-0202-2024Class IIRX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000September 6, 2023
Z-0199-2024Class IIRX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbishedSeptember 6, 2023
Z-0198-2024Class IIRX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040September 6, 2023
Z-2609-2023Class IILiquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215August 3, 2023
Z-2448-2023Class IIRandox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration July 19, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
DEN240035ConcizuTrace™ ELISAMay 22, 2025
K230890ISE ElectrodesSeptember 8, 2023
K182042Randox Calcium (Ca)October 23, 2018
K162200Randox RX Daytona Plus Magnesium (MG)April 28, 2017
K152085Liquid CO2-2 (LCO2-2)February 24, 2016
K153435Direct HDL Cholesterol (HDL)January 8, 2016
K150654CholesterolSeptember 29, 2015
K131554RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENTJanuary 9, 2014
K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORNovember 21, 2013
K132156RANDOX CSF CONTROLS LEVELS 2 AND 3October 23, 2013
K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2August 8, 2013
K131999HBA1C CONTROL, LEVEL 1 AND LEVEL 2July 26, 2013
K131776ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3July 18, 2013
K121603RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3November 20, 2012
K113720RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3September 20, 2012
K121746RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)July 11, 2012
K121588RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3June 20, 2012
K113751RANDOX COCAINE METABOLITEMay 8, 2012
K112337RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVELDecember 1, 2011
K102346RANDOX DIGOXIN ASSAYOctober 14, 2011