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.

51–75 of 79

  • LowFDA (Devices)·Z-1100-2020·2020-02-12

    Randox Liquid Clinical Chemistry Control Recalled for Transcription Error

    Randox Laboratories is recalling Liquid Clinical Chemistry Control lot 1021 UE due to a transcription error in the Lipase value.

    Product
    Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0283-2020·2019-11-13

    Randox Liquid Protein Calibrators Recalled for Rheumatoid Factor Value Adjustment

    Randox Laboratories is recalling 100 kits of Liquid Protein Calibrators because the assigned value for Rheumatoid Factor over-recovered against the reference material. The calibrator values have been adjusted to re-align to the reference material.

    Product
    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, Prealb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0282-2020·2019-11-13

    Randox Rheumatoid Factor Standard Recalled for Value Adjustment

    Randox Laboratories is recalling 17 Rheumatoid Factor Standard kits because assigned values over-recovered against reference material. The values have been adjusted to align with the reference standard.

    Product
    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 s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2557-2019·2019-10-02

    Randox Urinalysis Control Level 2 Recalled for Incorrect Leukocyte Range

    Randox Laboratories is recalling Randox Urinalysis Control Level 2 kits because the leukocyte range for the Siemens Multistix method was incorrect.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2490-2019·2019-09-18

    Randox Calibration Serum Recalled for Incorrect Analyte Targets

    Randox Laboratories is recalling calibration sera due to realigned targets for AST and ALT. The recall affects 307 kits distributed nationwide and in several foreign locations.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1785-2019·2019-06-26

    Randox Liquid Cardiac Control Recalled for Potential Concentration Decrease

    Randox Laboratories is recalling specific lots of Liquid Cardiac Control due to potential decreased NTproBNP concentration readings on Siemens Dimension EXL LOCI analyzers.

    Product
    Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1255-2019·2019-05-08

    Randox G-6-PDH Normal Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 10 kits of G-6-PDH Normal Control because the target values and ranges in specific lots are incorrect.

    Product
    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
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1254-2019·2019-05-08

    Randox G-6-PDH Deficient Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 14 kits of G-6-PDH Deficient Control because the target values and ranges in specific lots are incorrect.

    Product
    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
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1106-2019·2019-04-17

    Randox Immunoassay Controls Recalled for Incorrect Analyzer Target Value

    Randox Laboratories is recalling Immunoassay Premium Plus Controls due to an incorrect target value listed on the analyzer value sheet.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1107-2019·2019-04-17

    Randox Liquid Immunoassay Premium Controls Recalled for Incorrect Target Value

    Randox Laboratories is recalling Liquid Immunoassay Premium Controls because the target value for uptake is incorrect on the value sheet.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1105-2019·2019-04-17

    Randox Immunoassay Premium Controls Recalled for Incorrect Analyzer Target Values

    Randox Laboratories is recalling 58 units of Immunoassay Premium Controls due to an incorrect target value listed on the analyzer value sheet.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1057-2019·2019-04-03

    Randox Blood Gas Control Level 2 Recalled for pH Range Error

    Randox Laboratories is recalling Blood Gas Control Level 2 kits due to an error in the assignment of the control range pH.

    Product
    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: Calc
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1018-2019·2019-03-27

    Randox Fructosamine Control 3 Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 133 kits of Fructosamine Control 3 because the assigned value was decreased by 25%. The product is used for in vitro calibration.

    Product
    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.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1017-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 141 kits of Fructosamine Control 1 because the assigned value was decreased by 25%.

    Product
    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.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1016-2019·2019-03-27

    Randox Fructosamine Calibrator Recall Due to Value Reassignment

    Randox Laboratories is recalling 85 kits of Fructosamine Calibrator FR2993 because the assigned value was decreased by 25%.

    Product
    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0839-2019·2019-02-27

    Randox Calcium Reagent Recall for Potential Carryover Errors

    Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover, which may cause inaccurate test results.

    Product
    Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0840-2019·2019-02-27

    Randox Calcium Reagent Recall for Potential Carryover Errors

    Randox Laboratories is recalling Calcium reagents due to a technical bulletin update regarding reagent carryover. This issue may cause falsely elevated or decreased results in patient and QC samples.

    Product
    Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0660-2019·2019-01-02

    Randox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections

    Randox Laboratories is recalling SP CAL (LIQ) calibrators because value sheets were modified to improve alignment for specific assays.

    Product
    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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0380-2019·2018-11-14

    Randox Liquid Cardiac Control CQ5051 Recalled for Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5051 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5051
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0382-2019·2018-11-14

    Randox Recalls Liquid Cardiac Control CQ5053 Due to Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5053 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5053
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0381-2019·2018-11-14

    Randox Recalls Liquid Cardiac Control CQ5052 Due to Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5052 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5052
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2575-2018·2018-08-08

    Randox Liquid Cardiac Control Level 3 Recalled for Precision Issues

    Randox Laboratories is recalling Liquid Cardiac Control - Level 3 due to unacceptable variation between vials that may delay Troponin T test results.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2280-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 3 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2278-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2279-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
    Category
    Medical Device
    Distribution
    6 states

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.