Randox Laboratories Ltd.
79 recalls on record · Latest: Jul 31, 2024
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Agency notice ledger
Federal filing book Randox Laboratories Ltd. MID-BOOK · SINGLE-AGENCY
#229 of 14,151 · 79 notices · 0.076% archive
- BOOK 79 notices
- RANK #229 of 14,151
- SHARE 0.076% archive
- AGENCY FDA Devices (79)
- CAT medical devices
- CATS 1 category
- LATEST Jul 31, 2024
- PHOTO Abiomed, Inc.
Nearest notice-volume peer: Abiomed, Inc. (0 notice gap)
Randox Laboratories Ltd. accounts for about 0.076% of the 104,423-notice archive on 79 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
How Randox Laboratories Ltd. compares to 14,151 recalling firms
Randox Laboratories Ltd. ranks 229th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Randox Laboratories Ltd. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
79 229th of 14151 higher than 13,921 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Randox Laboratories Ltd. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Ice Cream Hou…
Ice Cream House
80 notices
- Randox Labora… (this)
Randox Laboratories Ltd.
79 notices
- Abiomed, Inc.
Abiomed, Inc.
79 notices
- Key Pharmacy
Key Pharmacy and Compounding Center
79 notices
- Lyons Magnus,…
Lyons Magnus, Inc
79 notices
- Suzuki
Suzuki
79 notices
What this shows Randox Laboratories Ltd. holds about 0.076% of archive notices alongside 79 distinct filings.
FDA Devices Moderate Jul 31, 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
FDA Devices Low May 15, 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
FDA Devices Moderate May 15, 2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
FDA Devices Moderate Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
FDA Devices Moderate Apr 24, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
FDA Devices Moderate Apr 3, 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
FDA Devices Moderate Mar 27, 2024
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
FDA Devices Moderate Feb 14, 2024
RX Series Copper (Cu) Assay Ref. Number CU2340
FDA Devices Moderate Jan 24, 2024
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Devices Moderate Jan 24, 2024
Calibration Serum Level 3 CAL2351
FDA Devices Moderate Jan 24, 2024
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
FDA Devices Low Jan 10, 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
FDA Devices Moderate Dec 13, 2023
RANDOX Total Bilirubin.
FDA Devices Moderate Nov 8, 2023
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
FDA Devices Moderate Nov 8, 2023
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
FDA Devices Moderate Nov 8, 2023
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
FDA Devices Moderate Nov 8, 2023
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
FDA Devices Moderate Nov 8, 2023
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
FDA Devices Moderate Sep 27, 2023
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
FDA Devices Moderate Aug 30, 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
FDA Devices Moderate Aug 30, 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
FDA Devices Moderate Aug 16, 2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
FDA Devices Low Jul 5, 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
FDA Devices Low Jul 5, 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
FDA Devices Moderate Jan 11, 2023
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
FDA Devices Moderate Jan 11, 2023
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
FDA Devices Moderate Jan 11, 2023
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
FDA Devices Moderate Dec 14, 2022
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
FDA Devices Moderate Dec 14, 2022
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
FDA Devices Moderate Sep 28, 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.
FDA Devices Low Jul 27, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
FDA Devices Low Jul 27, 2022
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
FDA Devices Moderate Jul 27, 2022
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
FDA Devices Low May 25, 2022
CK MB Calibrator, Catalogue Number CK2393
FDA Devices Moderate Dec 8, 2021
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
FDA Devices Moderate Jul 28, 2021
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Devices Moderate Jul 14, 2021
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
FDA Devices Moderate May 19, 2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
FDA Devices Moderate Dec 16, 2020
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
FDA Devices Moderate Dec 16, 2020
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
FDA Devices Moderate Sep 23, 2020
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - 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.
FDA Devices Moderate Sep 23, 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.
FDA Devices Moderate Sep 23, 2020
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Devices Moderate Sep 23, 2020
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Devices Moderate Sep 9, 2020
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Devices Moderate Sep 9, 2020
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
FDA Devices Moderate Aug 12, 2020
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
FDA Devices Moderate Aug 12, 2020
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
FDA Devices Moderate Aug 12, 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.
FDA Devices Moderate Apr 1, 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.
Randox Laboratories Ltd. carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (79 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Randox Laboratories Ltd.? ▼
PlainRecalls indexes 79 distinct federal recall events naming Randox Laboratories Ltd., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Randox Laboratories Ltd. sit among other recalling firms? ▼
Randox Laboratories Ltd. ranks #229 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Randox Laboratories Ltd.'s notices? ▼
FDA Devices accounts for 79 of this firm's 79 indexed notices.
What product category dominates Randox Laboratories Ltd.'s filing book? ▼
Filings for Randox Laboratories Ltd. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Randox Laboratories Ltd.: 79 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Randox Laboratories Ltd.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026