The Recall Desk

Manufacturer

Randox Laboratories Ltd.

79 recalls in our database name Randox Laboratories Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
79
Critical
0
Severe
1
Most recent
2024-07-31

Of the 79 recalls from Randox Laboratories Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 79

  • ModerateFDA (Devices)·Z-2425-2024·2024-07-31

    Cystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance

    Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.

    Product
    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2024·2024-05-15

    Randox Clinical Chemistry Calibration Serum Recalled for Measurement Bias

    Randox Laboratories has recalled Clinical Chemistry Calibration Serum (Cal2351/Cal10388) due to negative bias in inorganic phosphate measurements on RX Series instruments. The issue could affect the accuracy of clinical chemistry test results.

    Product
    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1786-2024·2024-05-15

    Evidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy

    Randox Laboratories is recalling 40 units of the Evidence MultiSTAT analyzer because a foam gasket defect may allow light to leak into the camera during testing, potentially affecting result accuracy and delaying reporting.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2024·2024-04-24

    Microalbumin Calibrator Series Recall Due to Measurement Accuracy Issue

    FDA recalls Microalbumin Calibrator Series due to negative measurement bias that may misclassify patient results. Laboratories using affected batches should review quality control data and consider recalibration.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2024·2024-04-24

    Microalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification

    Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.

    Product
    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2024·2024-04-03

    Cystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias

    Randox Laboratories is recalling Cystatin C Calibrator Series CVS 2699 because it runs with negative bias compared to other methods, which could affect test accuracy on automated analyzers.

    Product
    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1328-2024·2024-03-27

    Liquid Protein Calibrators recalled for reference material realignment correction

    Randox Laboratories is recalling 1,764 units of Liquid Protein Calibrators used in immunoassays due to realignment of C3 and Haptoglobin to the correct reference material standard. Distribution was limited to seven U.S. states.

    Product
    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0992-2024·2024-02-14

    RX Series Copper Assay Requires Modified Testing Order

    Randox Laboratories issued a technical bulletin stating that RX Series Copper Assay tests must not be run directly after Total Protein tests, as this could produce falsely elevated copper results.

    Product
    RX Series Copper (Cu) Assay Ref. Number CU2340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2024·2024-01-24

    Calibration Serum with Mis-assigned Alkaline Phosphatase Target

    Randox Calibration Serum Level 3 has an incorrect Alkaline Phosphatase target value (approximately 10% off) affecting clinical chemistry testing on RX Series instruments.

    Product
    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2024·2024-01-24

    Medical Diagnostic Calibration Serum Recalled for Positive Measurement Bias

    Randox Laboratories is recalling Calibration Serum Level 3 (CAL2351) distributed in the US and Puerto Rico because it exhibits a positive bias in CK Total measurements on RX Series instruments, potentially affecting test accuracy by up to 13%.

    Product
    Calibration Serum Level 3 CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2024·2024-01-24

    Medical Device Calibration Serums Recalled Due to Instructional Transcription Errors

    Randox Laboratories has recalled multiple calibration serum products due to transcription errors in the Instructions for Use, which contain incorrect target values for several analytes.

    Product
    Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0624-2024·2024-01-10

    Serology ToRCH positive control specimen recalled for decreased HSV reactivity

    Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0501-2024·2023-12-13

    RANDOX Total Bilirubin Reagent Recall Due to Elevated Patient Results

    Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.

    Product
    RANDOX Total Bilirubin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2024·2023-11-08

    RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results

    Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.

    Product
    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2024·2023-11-08

    RX Daytona Plus clinical chemistry analyzer may report incorrect test results

    The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.

    Product
    RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2024·2023-11-08

    RX Daytona Plus Clinical Chemistry Analyzer Rerun Settings Malfunction

    Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.

    Product
    RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2024·2023-11-08

    RX Modena Clinical Chemistry Analyzer Recalled for Incorrect Rerun Results

    Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.

    Product
    RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2024·2023-11-08

    RX Imola Clinical Chemistry Analyzer rerun feature may report results incorrectly

    RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.

    Product
    RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2023·2023-09-27

    Chemistry Quality Control Material Recalled for Transcription Error in Instructions

    Randox Laboratories recalled Liquid Assayed Chemistry Control Premium Plus Level 3 due to incorrect standard deviation values in the product instructions. The error could affect patient result reporting, but the correct operating values remain available.

    Product
    Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2448-2023·2023-08-30

    FDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error

    Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.

    Product
    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
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2446-2023·2023-08-30

    Randox Liquid Urine Control Level 2 Recalled for Analytical Accuracy Issues

    Randox Liquid Urine Control Level 2 (Lot 1209UC) is recalled for incorrect hCG and cortisol values and a transcription error in instructions. The defects may delay patient test reporting.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2023·2023-08-16

    Randox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk

    FDA recalls Randox RX Series Urea test kits because carryover from prior LDL-cholesterol tests may produce falsely low results, up to 11% below accurate values, potentially delaying diagnosis.

    Product
    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2023·2023-07-05

    FDA Recalls Immunoassay Quality Control Material for Out-of-Range Values

    Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.

    Product
    Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2022-2023·2023-07-05

    Immunoassay Quality Control Material Recalled for Out-of-Range Values

    Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.

    Product
    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
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0904-2023·2023-01-11

    Laboratory quality control material with degraded potency affecting diagnostic verification

    Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Randox Laboratories

UK diagnostics company

Country
United Kingdom
Founded
1982

Source: Wikidata (Q7292021), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.