Randox Laboratories Limited
Randox Laboratories Limited holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 13 FDA device recalls on record.
Top product codes for Randox Laboratories Limited
FDA recalls by Randox Laboratories Limited
10 most recent of 13- Z-1018-2025 — Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
- Z-1017-2025 — Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
- Z-1349-2020 — RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
- Z-0413-2020 — Randox Liquid Cardiac Controls Catalogue Number CQ5052.
- Z-0414-2020 — Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
- Z-0412-2020 — Randox Liquid Cardiac Controls Catalogue Number CQ5051
- Z-0367-2020 — RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
- Z-2083-2019 — RX Daytona, Model Nos. RX4040 and RX4041
- Z-2084-2019 — RX Imola, Model Nos. RX4900
- Z-2150-2019 — Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
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 Limited
- K250741 — Evidence MultiSTAT DOA Urine MultiPlex
- K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
- K221550 — Evidence MultiSTAT DOA Urine MultiPlex
- K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)
- K161691 — Direct LDL Cholesterol (LDL)
- K152343 — Direct Bilirubin
- K152344 — Total Bilirubin
- K150819 — Triglycerides
- K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
- K142181 — RANDOX ALDOLASE CALIBRATION SERUM
- K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
- K140393 — RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
- K130337 — RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
- K113747 — RANDOX OPIATES ASSAY
- K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
- K110534 — RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
- K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
- K041361 — RANDOX TRI LEVEL CARDIAC CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.