PlainRecalls

Randox Laboratories Ltd.

Compiled from official public sources by the editorial team.

79 recalls on record · Latest: Jul 31, 2024

Randox Laboratories Ltd. Recall Insight

Randox Laboratories Ltd. appears on 79 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.078% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 31, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 43 moderate, and 7 lower-severity recalls. Affected-unit counts are disclosed on 48 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Apr 1, 2020 to Jul 31, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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…

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…

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 chemist…

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 2…

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 ant…

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, Ferrit…

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…

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. Ca…

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 ana…

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 syst…

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 Numb…

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 syste…

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,…

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 Dehydr…

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…

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 determ…

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 determina…

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 determinati…

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 qualit…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.