Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
This page shows every FDA and USDA recall linked to Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
72
Total Recalls
2016
First Recall
2024
Most Recent
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on a...
Jul 24, 2024
· Device
Active
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay
Catalog Number: MA2426
Apr 17, 2024
· Device
Active
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay
Catalog Number: MA1567
Apr 17, 2024
· Device
Active
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on aut...
Mar 22, 2024
· Device
Active
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM a...
Mar 20, 2024
· Device
Active
RX Series Copper (Cu) Assay Ref. Number CU2340
Feb 6, 2024
· Device
Active
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-S...
Jan 18, 2024
· Device
Active
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays
Catalog Number: CAL2351
Jan 18, 2024
· Device
Active
Calibration Serum Level 3
CAL2351
Jan 18, 2024
· Device
Active
RANDOX Total Bilirubin.
Dec 6, 2023
· Device
Active
RX Modena-IVD Clinical Chemistry Analyser
Catalog Number: RX9000
Oct 31, 2023
· Device
Active
RX Imola-IVD Clinical Chemistry Analyzer
Catalog Number: RX4900. RX4900R (refurbished)
Oct 31, 2023
· Device
Active
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser
Catalog Number: RX4040
Oct 31, 2023
· Device
Active
RX Monaco-IVD Clinical Chemistry Analyser
Catalog Number: RX5000
Oct 31, 2023
· Device
Active
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser
(1) RX4041, (2) RX4041R (refurbished)
Oct 31, 2023
· Device
Active
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Sep 19, 2023
· Device
Active
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase,...
Aug 23, 2023
· Device
Active
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Co...
Aug 23, 2023
· Device
Active
Randox RX Series Urea Enzymatic Kinetic Assay
Ref. Numbers:
(1) UR3825
(2) UR3873
(3) UR8334
(4) UR8070 (M...
Aug 9, 2023
· Device
Active
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor...
Jun 28, 2023
· Device
Active
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accura...
Jun 28, 2023
· Device
Active
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on...
Jan 5, 2023
· Device
Active
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IM3834
Dec 3, 2022
· Device
Terminated
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IA383...
Dec 3, 2022
· Device
Terminated
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, An...
Sep 19, 2022
· Device
Terminated
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma.
Catalog N...
Jun 22, 2022
· Device
Terminated
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Jun 9, 2022
· Device
Terminated
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Jun 9, 2022
· Device
Terminated
CK MB Calibrator, Catalogue Number CK2393
Mar 25, 2022
· Device
Terminated
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum
REF: CH200
Nov 1, 2021
· Device
Terminated
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA
Catalog Number: FA115
May 10, 2021
· Device
Terminated
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Apr 28, 2021
· Device
Terminated
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator.
Catalogue Number: CAL2351
Mar 29, 2021
· Device
Terminated
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and ur...
Nov 13, 2020
· Device
Terminated
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma...
Nov 13, 2020
· Device
Terminated
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantit...
Aug 11, 2020
· Device
Terminated
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative i...
Aug 11, 2020
· Device
Terminated
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for...
Feb 18, 2020
· Device
Active
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Dec 13, 2019
· Device
Terminated
Liquid Protein Calibrators (SP CAL (LIQ))
Catalogue Number: IT2691
GTIN: 05055273204032
Product Usage: Liquid...
Aug 9, 2019
· Device
Terminated
Rheumatoid Factor Standard (RF CAL)
Catalogue Number: RF2301
GTIN: 05055273205039
Product Usage: The Randox R...
Aug 9, 2019
· Device
Terminated
Randox Urinalysis Control Level 2 (IVD)
Ref: UC5034 - Product Usage: Product is intended for in vitro diagn...
Jul 25, 2019
· Device
Terminated
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. R...
Jul 12, 2019
· Device
Terminated
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618
Product Usage:
This product is intended f...
Apr 3, 2019
· Device
Terminated
G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617
Product Usage:
This product is intende...
Apr 3, 2019
· Device
Terminated