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.

76–79 of 79

  • ModerateFDA (Devices)·Z-1631-2018·2018-05-16

    Randox Lipase Assay Recalled for Potential Contamination on Rx Instruments

    Randox Laboratories is recalling Lipase Assay kits due to potential contamination risks on Rx instruments. The recall affects specific lots distributed in West Virginia and Puerto Rico.

    Product
    Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatme
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0285-2018·2018-01-03

    Randox HbA1c Reagent Recalled for Low Calibration Absorbance

    Randox Laboratories is recalling 90 kits of HbA1c reagent (Batch 414553) due to low calibration absorbance that may affect performance.

    Product
    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0123-2017·2016-10-26

    Randox Lipase Test System Recalled for Carryover Interference

    Randox Laboratories is recalling 18 units of Lipase test kits due to carryover interference when run near LDL or Triglycerides assays.

    Product
    Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2017·2016-10-12

    Randox IgE Calibrator Series Recall for Value Alignment

    Randox Laboratories is recalling IgE Calibrator Series units to align value assignments with the 3rd International Standard for human serum IgE.

    Product
    IgE Calibrator Series
    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.