Randox Laboratories, Ltd.
Randox Laboratories, Ltd. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2025, with 79 FDA device recalls on record.
Top product codes for Randox Laboratories, Ltd.
FDA recalls by Randox Laboratories, Ltd.
10 most recent of 79- 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
- 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
- Z-1759-2024 — Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
- Z-1328-2024 — Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
- 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
- Z-1593-2024 — Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
- Z-1594-2024 — Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
- Z-0992-2024 — RX Series Copper (Cu) Assay Ref. Number CU2340
- Z-0753-2024 — Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
- Z-0752-2024 — Calibration Serum Level 3 CAL2351
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Randox Laboratories, Ltd.
1–100 of 116- DEN240035 — ConcizuTrace ELISA
- K230890 — ISE Electrodes
- K182042 — Randox Calcium (Ca)
- K162200 — Randox RX Daytona Plus Magnesium (MG)
- K152085 — Liquid CO2-2 (LCO2-2)
- K153435 — Direct HDL Cholesterol (HDL)
- K150654 — Cholesterol
- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
- K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3
- K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
- K131999 — HBA1C CONTROL, LEVEL 1 AND LEVEL 2
- K131776 — ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
- K121603 — RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
- K113720 — RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
- K121746 — RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
- K121588 — RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
- K113751 — RANDOX COCAINE METABOLITE
- K112337 — RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
- K102346 — RANDOX DIGOXIN ASSAY
- K110904 — RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
- K092268 — RANDOX BARITURATES ASSAY
- K092266 — RANDOX METHAMPHETAMINE ASSAY
- K092269 — CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
- K092275 — RANDOX ECSTASY (MDMA) ASSAY
- K092272 — RANDOX METHADONE ASSAY
- K092258 — RANDOX METABOLITE (EDDP) ASSAY
- K092273 — RANDOX ETHANOL ASSAY
- K092274 — RANDOX BENZODIAZEPINE ASSAY
- K061056 — RANDOX LIQUID PROTEIN CALIBRATOR
- K052914 — RX IMOLA
- K053153 — RANDOX CALIBRATION SERUM
- K050179 — RANDOX BENZODIAZEPINE CLASS ASSAY
- K043266 — RANDOX URINE CONTROLS
- K043268 — SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
- K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
- K043071 — RANDOX PHENCYCLIDINE ASSAY
- K041142 — RANDOX CANNABINOIDS ASSSAY
- K041143 — RANDOX BARBITURATE ASSAY
- K041144 — RANDOX OPIATES ASSAY
- K040379 — RANDOX IMMUNOASSAY CONTROL
- K033884 — RANDOX AMIKACIN
- K040350 — RANDOX AMPHETAMINE CLASS ASSAY
- K040570 — RANDOX METHADONE ASSAY
- K040351 — RANDOX LIQUID CRP CONTROLS
- K033278 — RANDOX URIC ACID
- K030360 — RANDOX EVIDENCE
- K024014 — RANDOX RX DAYTONA
- K031608 — RANDOX LIQUID PROTEIN CALIBRATOR
- K030873 — RANDOX AMMONIA
- K023763 — RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
- K021897 — RANDOX HAEMOGLOBIN A1C
- K022682 — RANDOX C-REACTIVE PROTEIN CALIBRATOR
- K023158 — RANDOX APOLIPOPROTEIN CALIBRATOR
- K022591 — RANDOX LIPID CONTROL
- K011771 — RANDOX THEOPHYLLINE
- K011648 — RANDOX CARBAMAZEPINE
- K011649 — RANDOX VALPROIC ACID
- K012112 — RANDOX DIGITOXIN
- K011393 — RANDOX PHENYTOIN
- K011568 — RANDOX LIPOPROTEIN
- K012978 — RANDOX GENTAMICIN
- K012318 — RANDOX THERAPEUTIC DRUG CALIBRATOR
- K012319 — RANDOX HUMAN ASSSAYED DRUG CONTROL
- K011302 — RANDOX DIGOXIN
- K011303 — RANDOX PHENOBARBITAL
- K010855 — RANDOX IGE
- K010700 — RANDOX MYOGLOBIN
- K003346 — RANDOX GLUCOSE (GOD/PAP)
- K002585 — RANDOX TRANSFERRIN
- K002674 — RANDOX MICROALBUMIN
- K001009 — RANDOX C-REACTIVE PROTEIN
- K000661 — RANDOX PREALBUMIN
- K000375 — RANDOX CALCIUM
- K000662 — RANDOX FERRITIN
- K000483 — RANDOX ALBUMIN
- K000468 — RANDOX COMPLEMENT C4
- K000469 — RANDOX COMPLEMENT C3
- K984494 — RANDOX ALBUMIN
- K982529 — RANDOX DIRECT LDL CHOLESTEROL
- K982341 — DIRECT HDL-CHOLESTROL LIQUID
- K973993 — RANDOX CREATININE
- K974606 — RANDOX MAGNESIUM
- K974607 — RANDOX CALCIUM
- K974605 — RANDOX INORGANIC PHOSPHOROUS
- K974604 — RANDOX IRON
- K973995 — RANDOX BILIRUBIN
- K972220 — RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
- K972608 — RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
- K971825 — PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
- K970735 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K970684 — LACTATE DEHYDROGENASE (LD)
- K953210 — GLUCOSE (HEXOKINASE) KIT
- K961169 — RHEUMATOID FACTOR LATEX SLIDE TEST KIT
- K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT
- K955489 — CALIBRATION SERUM LEVEL 1 & 2
- K951222 — TOTAL PROTEIN (URINE)
- K955794 — IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
- K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
- K955798 — IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.