Randox Laboratories Ltd.: FDA recalls

FDA enforcement reports name Randox Laboratories Ltd. as the recalling firm in 52 events. The events have 79 product records. The recalls started from 2016 to 2024. All the events are device recalls.

See the 52 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

52 events, newest first.

FDA enforcement events of Randox Laboratories Ltd.
Initiated	Product (first record)	Type	Class	Records	Status
7 Jun 2024	RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004	Device	Class II	1	Ongoing
5 Apr 2024	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	Device	Class III	1	Ongoing
5 Mar 2024	Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.	Device	Class II	1	Ongoing
1 Mar 2024	Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.	Device	Class II	1	Ongoing
14 Feb 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	Device	Class II	1	Ongoing
31 Jan 2024	Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567	Device	Class II	2	Ongoing
29 Nov 2023	RX Series Copper (Cu) Assay Ref. Number CU2340	Device	Class II	1	Ongoing
20 Nov 2023	Calibration Serum Level 3 CAL2351	Device	Class II	1	Ongoing
20 Nov 2023	Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351	Device	Class II	1	Ongoing
13 Nov 2023	Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)	Device	Class II	1	Ongoing
6 Nov 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	Device	Class III	1	Ongoing
11 Oct 2023	RANDOX Total Bilirubin.	Device	Class II	1	Ongoing
6 Sep 2023	RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040	Device	Class II	5	Ongoing
3 Aug 2023	Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215	Device	Class II	1	Ongoing
19 Jul 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	Device	Class II	1	Ongoing
21 Jun 2023	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…	Device	Class II	1	Ongoing
13 Jun 2023	Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)	Device	Class II	1	Ongoing
4 May 2023	Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640	Device	Class III	2	Ongoing
22 Nov 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	Device	Class II	3	Ongoing
1 Nov 2022	IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832	Device	Class II	2	Terminated
1 Aug 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, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.	Device	Class II	1	Terminated
22 Jun 2022	Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0	Device	Class II	1	Terminated
9 Jun 2022	Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD	Device	Class III	2	Terminated
25 Mar 2022	CK MB Calibrator, Catalogue Number CK2393	Device	Class III	1	Terminated
1 Nov 2021	RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200	Device	Class II	1	Terminated
10 May 2021	NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115	Device	Class II	1	Terminated
28 Apr 2021	Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R	Device	Class II	1	Terminated
29 Mar 2021	Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351	Device	Class II	1	Terminated
13 Nov 2020	Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880	Device	Class II	2	Terminated
11 Aug 2020	Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.	Device	Class II	2	Terminated
30 Jul 2020	AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma	Device	Class II	2	Terminated
10 Jul 2020	Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent	Device	Class II	2	Terminated
26 Jun 2020	Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.	Device	Class II	3	Terminated
18 Feb 2020	Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.	Device	Class II	1	Ongoing
13 Dec 2019	Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml	Device	Class III	1	Terminated
9 Aug 2019	Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to…	Device	Class II	2	Terminated
25 Jul 2019	Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.	Device	Class III	1	Terminated
12 Jul 2019	This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide…	Device	Class III	1	Terminated
3 Apr 2019	G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes	Device	Class II	2	Terminated
11 Mar 2019	Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053	Device	Class II	1	Terminated
13 Feb 2019	Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH,…	Device	Class II	1	Terminated
7 Feb 2019	Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert	Device	Class III	3	Terminated
4 Dec 2018	Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904	Device	Class II	2	Terminated
3 Dec 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.	Device	Class II	3	Ongoing
19 Nov 2018	SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.	Device	Class II	1	Terminated
2 Oct 2018	Liquid Cardiac Control, CQ5051	Device	Class II	3	Terminated
8 Jun 2018	Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.	Device	Class II	1	Terminated
22 May 2018	Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682	Device	Class II	3	Terminated
2 Mar 2018	Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as…	Device	Class II	1	Terminated
7 Jun 2017	Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3:…	Device	Class II	1	Terminated
7 Sep 2016	IgE Calibrator Series	Device	Class II	1	Terminated
2 Aug 2016	Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Randox Laboratories Ltd.: events for each product type
Type		Events
Device		52

Randox Laboratories Ltd.: events in each class
Class		Events
Class II		43
Class III		9

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 21

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Randox Laboratories Ltd., by the year that the recall started. The largest year is 2023, with 12 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Randox Laboratories Ltd.: FDA recalls. https://recallregister.com/firm/randox-laboratories-ltd/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Randox Laboratories Ltd. have?: Class II: 43 events. Class III: 9 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Randox Laboratories Ltd.?: FDA event 94858, which the firm started on 7 Jun 2024. The first product in the record is: RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
How many FDA recalls of Randox Laboratories Ltd. have the status Ongoing?: 21 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.