Randox Laboratories, Limited
Kearneysville, WV, US
RANDOX LABORATORIES LIMITED appears in FDA device records in Kearneysville, WV. FDA records list 134 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 98 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Randox Laboratories, Limited carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- RANDOX LABORATORIES-US, LTDregistration
510(k) clearance history
Showing 50 of 134FDA records hold 134 510(k) clearances for Randox Laboratories, Limited between 1992 and 2026. The busiest year on record is 2001, with 11. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 5 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 6 |
| 1996 | 9 |
| 1997 | 6 |
| 1998 | 7 |
| 1999 | 1 |
| 2000 | 8 |
| 2001 | 11 |
| 2002 | 8 |
| 2003 | 5 |
| 2004 | 10 |
| 2005 | 5 |
| 2006 | 3 |
| 2010 | 4 |
| 2011 | 8 |
| 2012 | 8 |
| 2013 | 6 |
| 2014 | 5 |
| 2015 | 2 |
| 2016 | 4 |
| 2017 | 3 |
| 2018 | 1 |
| 2023 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | Substantially Equivalent | |
| DEN240035 | ConcizuTrace™ ELISA | SES | Unknown | |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | DJG | Substantially Equivalent | |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | DJG | Substantially Equivalent | |
| K230890 | ISE Electrodes | CEM | Substantially Equivalent | |
| K182042 | Randox Calcium (Ca) | CJY | Substantially Equivalent | |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | JGJ | Substantially Equivalent | |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | CJE | Substantially Equivalent | |
| K161691 | Direct LDL Cholesterol (LDL) | MRR | Substantially Equivalent | |
| K152085 | Liquid CO2-2 (LCO2-2) | KHS | Substantially Equivalent | |
| K152343 | Direct Bilirubin | JFM | Substantially Equivalent | |
| K152344 | Total Bilirubin | JFM | Substantially Equivalent | |
| K153435 | Direct HDL Cholesterol (HDL) | LBS | Substantially Equivalent | |
| K150654 | Cholesterol | CHH | Substantially Equivalent | |
| K150819 | Triglycerides | CDT | Substantially Equivalent | |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | JJY | Substantially Equivalent | |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | JIT | Substantially Equivalent | |
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | JJY | Substantially Equivalent | |
| K140393 | RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 | JJY | Substantially Equivalent | |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | JJE | Substantially Equivalent | |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | CGS | Substantially Equivalent | |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | JJY | Substantially Equivalent | |
| K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | DLJ | Substantially Equivalent | |
| K131999 | HBA1C CONTROL, LEVEL 1 AND LEVEL 2 | JJX | Substantially Equivalent | |
| K131776 | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 | JJX | Substantially Equivalent | |
| K130337 | RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 | JJY | Substantially Equivalent | |
| K121603 | RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 | JJY | Substantially Equivalent | |
| K113720 | RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 | JJY | Substantially Equivalent | |
| K113747 | RANDOX OPIATES ASSAY | DJG | Substantially Equivalent | |
| K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | JIS | Substantially Equivalent | |
| K121746 | RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) | JJX | Substantially Equivalent | |
| K121588 | RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 | JJX | Substantially Equivalent | |
| K113751 | RANDOX COCAINE METABOLITE | DIO | Substantially Equivalent | |
| K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 | JJY | Substantially Equivalent | |
| K112337 | RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL | JJY | Substantially Equivalent | |
| K102346 | RANDOX DIGOXIN ASSAY | KXT | Substantially Equivalent | |
| K110904 | RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 | JJY | Substantially Equivalent | |
| K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 | JJW | Substantially Equivalent | |
| K092268 | RANDOX BARITURATES ASSAY | DIS | Substantially Equivalent | |
| K092266 | RANDOX METHAMPHETAMINE ASSAY | DKB | Substantially Equivalent | |
| K092269 | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET | LDJ | Substantially Equivalent | |
| K092275 | RANDOX ECSTASY (MDMA) ASSAY | DKZ | Substantially Equivalent | |
| K092272 | RANDOX METHADONE ASSAY | DJR | Substantially Equivalent | |
| K092258 | RANDOX METABOLITE (EDDP) ASSAY | DJR | Substantially Equivalent | |
| K092273 | RANDOX ETHANOL ASSAY | DIC | Substantially Equivalent | |
| K092274 | RANDOX BENZODIAZEPINE ASSAY | JXM | Substantially Equivalent | |
| K061056 | RANDOX LIQUID PROTEIN CALIBRATOR | JIX | Substantially Equivalent | |
| K052914 | RX IMOLA | CEM | Substantially Equivalent | |
| K053153 | RANDOX CALIBRATION SERUM | JIX | Substantially Equivalent | |
| K050179 | RANDOX BENZODIAZEPINE CLASS ASSAY | JXM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004493545 | 3004493545 | RANDOX LABORATORIES LIMITED | 36 / 44 LARGY ROAD, CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey BT29 4RN GB | 2026 | and 114 more, listed in full below |
| 3014607865 | 3014607865 | RANDOX LABORATORIES LIMITED | 30 RANDALSTOWN ROAD, ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey BT41 4FL GB | 2026 | and 22 more, listed in full below |
| 2086993 | 3003059701 | RANDOX LABORATORIES-US, LTD | 515 INDUSTRIAL BOULEVARD, Kearneysville, WV 25430 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CDOAcid, Uric, Uricase (U.V.)
- DDZAlbumin, Fitc, Antigen, Antiserum, Control
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- DIHColorimetry, Cholinesterase
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CEMElectrode, Ion Specific, Potassium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- DBFFerritin, Antigen, Antiserum, Control
- CJCFructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
- CGAGlucose Oxidase, Glucose
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CISHydrazone Colorimetry, Ast/Sgot
- CZPIga, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- DDRMyoglobin, Antigen, Antiserum, Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- CIJSaccharogenic, Amylase
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- CEJTetraphenyl Borate, Colorimetry, Potassium
- DJCThin Layer Chromatography, Methamphetamine
- CFOTitrimetric, Magnesium
- DDGTransferrin, Antigen, Antiserum, Control
- CEIUranyl Acetate/Zinc Acetate, Sodium
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
Showing 25 of 98| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1018-2025 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757 | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | Class II | Open, Classified | |
| Z-1017-2025 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403 | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | Class II | Open, Classified | |
| Z-2425-2024 | RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004 | Cystatin C Reagent marketed without a 510 (k) | Class II | Open, Classified | |
| Z-1786-2024 | 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 | Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results. | Class III | Open, Classified | |
| Z-1759-2024 | Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests. | Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods. | Class II | Open, Classified | |
| Z-1328-2024 | Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution. | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. | Class II | Open, Classified | |
| Z-1369-2024 | Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699 | Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods | Class II | Open, Classified | |
| Z-1594-2024 | Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426 | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%. | Class II | Open, Classified | |
| Z-1593-2024 | Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567 | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%. | Class II | Open, Classified | |
| Z-0992-2024 | RX Series Copper (Cu) Assay Ref. Number CU2340 | Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results. | Class II | Open, Classified | |
| Z-0753-2024 | Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351 | Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples | Class II | Open, Classified | |
| Z-0752-2024 | Calibration Serum Level 3 CAL2351 | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%. | Class II | Open, Classified | |
| Z-0751-2024 | Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532) | There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value. | Class II | Open, Classified | |
| Z-0624-2024 | 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 | A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL. | Class III | Open, Classified | |
| Z-0501-2024 | RANDOX Total Bilirubin. | Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. | Class II | Open, Classified | |
| Z-0202-2024 | RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly. | Class II | Open, Classified | |
| Z-0201-2024 | RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly. | Class II | Open, Classified | |
| Z-0200-2024 | RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished) | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly. | Class II | Open, Classified | |
| Z-0199-2024 | RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished) | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly. | Class II | Open, Classified | |
| Z-0198-2024 | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly. | Class II | Open, Classified | |
| Z-2609-2023 | Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 | there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice. | Class II | Open, Classified | |
| Z-2448-2023 | 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 | As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following. | Class II | Open, Classified | |
| Z-2446-2023 | 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 clinical chemistry systems Catalog Number: UC5074 | (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes. | Class II | Open, Classified | |
| Z-2362-2023 | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena) | Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results. | Class II | Open, Classified | |
| Z-2022-2023 | Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633 | Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range | Class III | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Randox Laboratories, Limited edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain