The Recall Desk

Manufacturer

Randox Laboratories

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2023-04-05

Of the 6 recalls from Randox Laboratories we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–6 of 6

  • HighFDA (Devices)·Z-1286-2023·2023-04-05

    CRP Immunoturbidimetric Reagent Recalled for Positive Bias in Patient Samples

    Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.

    Product
    CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2059-2018·2018-06-13

    Randox RX Imola Analyzers Recalled for Software Termination Issue

    Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.

    Product
    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0970-2018·2018-03-21

    Randox Immunoassay Premium Plus Controls Recalled for Stability Issues

    Randox Laboratories is recalling Immunoassay Premium Plus Controls because the ACTH component does not meet the stability claims in the product instructions.

    Product
    Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0969-2018·2018-03-21

    Randox Recalls Immunoassay Premium Controls Due to Stability Claim Failure

    Randox Laboratories is recalling 117 kits of Immunoassay Premium Controls because the ACTH component does not meet the stated reconstituted stability claim in the product instructions for use.

    Product
    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2167-2017·2017-06-07

    Randox Liquid Urine Control Level 3 Recalled for Labeling Error

    Randox Laboratories is recalling 198 kits of Liquid Urine Control Level 3 due to a labeling error affecting Total Protein values.

    Product
    Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0762-2017·2016-12-21

    Randox Liquid Cardiac Controls Recalled for Decreased Analyte Recovery

    Randox Laboratories is recalling Randox Liquid Cardiac Controls Level 1, 2, and 3 because internal stability monitoring revealed decreased recovery of myoglobin and CKMB.

    Product
    The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Di
    Category
    Medical Device
    Distribution
    0 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.