The Recall Desk

Manufacturer

Randox Laboratories, Limited

13 recalls in our database name Randox Laboratories, Limited as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
1
Most recent
2025-01-29

Of the 13 recalls from Randox Laboratories, Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (8%) 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.

1–13 of 13

  • HighFDA (Devices)·Z-1017-2025·2025-01-29

    Randox Lipoprotein (a) assay distributed without required FDA clearance

    Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2025·2025-01-29

    Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled

    Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2020·2020-03-04

    Randox RX Daytona Plus Clinical Chemistry Analyzer Software Recall

    Randox Laboratories is recalling RX Daytona Plus clinical chemistry analyzers to fix software issues causing incorrect sample ordering and quality control flags.

    Product
    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is removing N-proBNP claims from Liquid Cardiac Controls due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Number CQ5052.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0414-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is recalling Liquid Cardiac Controls (CQ5053) to remove N-proBNP claims due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0412-2020·2019-11-27

    Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal

    Randox Laboratories is recalling Liquid Cardiac Controls (CQ5051) to remove N-proBNP claims due to decreased recovery in recent lots.

    Product
    Randox Liquid Cardiac Controls Catalogue Number CQ5051
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0367-2020·2019-11-20

    Randox NEFA FA115 Recalled for Performance Failure

    Randox Laboratories is recalling NEFA FA115 Lot 485343 because it is not meeting performance claims and should not be used for testing.

    Product
    RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2150-2019·2019-08-14

    Randox Human Assayed Multi-Sera Level 2 Recalled for Incorrect Control Values

    Randox Laboratories is recalling Human Assayed Multi-Sera Level 2 controls due to incorrectly assigned target and range values for specific analytes.

    Product
    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0937-2018·2018-03-21

    Randox Liquid Cardiac Control CQ5053 Recalled for Shelf-Life Labeling Error

    Randox is recalling 450 kits of Liquid Cardiac Control CQ5053 because the product does not meet its shelf-life claim, potentially causing test results to fall outside control ranges.

    Product
    Liquid Cardiac Control CQ5053
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0725-2017·2016-12-14

    Randox Magnesium IVD Reagent Recalled for Carryover Interference

    Randox Laboratories is recalling 15 units of Magnesium IVD reagents for the RX Imola analyser due to carryover interference from amylase tests.

    Product
    Magnesium on RX Imola analyser IVD
    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.