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 Low Feb 12, 2020
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Devices Moderate Nov 13, 2019
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimensi
FDA Devices Moderate Nov 13, 2019
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syp
FDA Devices Low Oct 2, 2019
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
FDA Devices Low Sep 18, 2019
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
FDA Devices Moderate Jun 26, 2019
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
FDA Devices Moderate May 8, 2019
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
FDA Devices Moderate May 8, 2019
G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
FDA Devices Low Apr 17, 2019
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
FDA Devices Low Apr 17, 2019
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
FDA Devices Low Apr 17, 2019
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
FDA Devices Moderate Apr 3, 2019
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
FDA Devices Moderate Mar 27, 2019
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
FDA Devices Moderate Mar 27, 2019
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
FDA Devices Moderate Mar 27, 2019
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
FDA Devices Moderate Feb 27, 2019
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
FDA Devices Moderate Feb 27, 2019
Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
FDA Devices Moderate Jan 2, 2019
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
FDA Devices Moderate Nov 14, 2018
Liquid Cardiac Control, CQ5053
FDA Devices Moderate Nov 14, 2018
Liquid Cardiac Control, CQ5052
FDA Devices Moderate Nov 14, 2018
Liquid Cardiac Control, CQ5051
FDA Devices Moderate Aug 8, 2018
Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
FDA Devices Moderate Jul 4, 2018
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
FDA Devices Moderate Jul 4, 2018
Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
FDA Devices Moderate Jul 4, 2018
Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
FDA Devices Moderate May 16, 2018
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
FDA Devices Moderate Jan 3, 2018
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Rea
FDA Devices Moderate Oct 26, 2016
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
FDA Devices Moderate Oct 12, 2016
IgE Calibrator Series
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