Randox Laboratories recalls
Randox Laboratories appears in 98 official U.S. recall notices indexed by RecallRadar, most recently on 2025-01-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers
FDA Device · Class II · 2025-01-29 · Randox Laboratories - Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers
FDA Device · Class II · 2025-01-29 · Randox Laboratories - RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers
FDA Device · Class II · 2024-07-31 · Randox Laboratories - Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs…
FDA Device · Class III · 2024-05-15 · Randox Laboratories - Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinic…
FDA Device · Class II · 2024-05-15 · Randox Laboratories - Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
FDA Device · Class II · 2024-04-24 · Randox Laboratories - Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
FDA Device · Class II · 2024-04-24 · Randox Laboratories - Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Numb…
FDA Device · Class II · 2024-04-03 · Randox Laboratories - Liquid Protein Calibrators
FDA Device · Class II · 2024-03-27 · Randox Laboratories - RX Series Copper (Cu) Assay Ref
FDA Device · Class II · 2024-02-14 · Randox Laboratories - Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Device · Class II · 2024-01-24 · Randox Laboratories - Calibration Serum Level 3 CAL2351
FDA Device · Class II · 2024-01-24 · Randox Laboratories - Calibration Serum Level 3. CAL 3, REF CAL2351
FDA Device · Class II · 2024-01-24 · Randox Laboratories - SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV…
FDA Device · Class III · 2024-01-10 · Randox Laboratories - RANDOX Total Bilirubin
FDA Device · Class II · 2023-12-13 · Randox Laboratories - RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
FDA Device · Class II · 2023-11-08 · Randox Laboratories - RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
FDA Device · Class II · 2023-11-08 · Randox Laboratories - RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
FDA Device · Class II · 2023-11-08 · Randox Laboratories - RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
FDA Device · Class II · 2023-11-08 · Randox Laboratories - RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900
FDA Device · Class II · 2023-11-08 · Randox Laboratories - Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
FDA Device · Class II · 2023-09-27 · Randox Laboratories - Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, C…
FDA Device · Class II · 2023-08-30 · Randox Laboratories - Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol,…
FDA Device · Class II · 2023-08-30 · Randox Laboratories - Randox RX Series Urea Enzymatic Kinetic Assay Ref
FDA Device · Class II · 2023-08-16 · Randox Laboratories - Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of ana…
FDA Device · Class III · 2023-07-05 · Randox Laboratories - Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibil…
FDA Device · Class III · 2023-07-05 · Randox Laboratories - CRP Immunoturbidimetric reagent
FDA Device · Class II · 2023-04-05 · Randox Laboratories - Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Cat…
FDA Device · Class II · 2023-01-11 · Randox Laboratories - Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoa…
FDA Device · Class II · 2023-01-11 · Randox Laboratories - Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoa…
FDA Device · Class II · 2023-01-11 · Randox Laboratories - IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
FDA Device · Class II · 2022-12-14 · Randox Laboratories - IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
FDA Device · Class II · 2022-12-14 · Randox Laboratories - 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,…
FDA Device · Class II · 2022-09-28 · Randox Laboratories - Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma
FDA Device · Class II · 2022-07-27 · Randox Laboratories - Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only)
FDA Device · Class III · 2022-07-27 · Randox Laboratories - Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161
FDA Device · Class III · 2022-07-27 · Randox Laboratories - CK MB Calibrator, Catalogue Number CK2393
FDA Device · Class III · 2022-05-25 · Randox Laboratories - RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
FDA Device · Class II · 2021-12-08 · Randox Laboratories - NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Device · Class II · 2021-07-28 · Randox Laboratories - Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
FDA Device · Class II · 2021-07-14 · Randox Laboratories - Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator
FDA Device · Class II · 2021-05-19 · Randox Laboratories - Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number:…
FDA Device · Class II · 2020-12-16 · Randox Laboratories - Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
FDA Device · Class II · 2020-12-16 · Randox Laboratories - Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lact…
FDA Device · Class II · 2020-09-23 · Randox Laboratories - AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Device · Class II · 2020-09-23 · Randox Laboratories - AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Device · Class II · 2020-09-23 · Randox Laboratories - Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination…
FDA Device · Class II · 2020-09-23 · Randox Laboratories - Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Device · Class II · 2020-09-09 · Randox Laboratories - Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Device · Class II · 2020-09-09 · Randox Laboratories - Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vi…
FDA Device · Class II · 2020-08-12 · Randox Laboratories