PlainRecalls

Randox Laboratories Ltd.

Compiled from official public sources by the editorial team.

79 recalls on record · Latest: Jul 31, 2024

Randox Laboratories Ltd. Recall Insight

Randox Laboratories Ltd. appears on 79 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.078% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 31, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 29 entries, severity tagging shows 0 critical, 23 moderate, and 6 lower-severity recalls. Affected-unit counts are disclosed on 26 of 29 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (29). The date window on this page runs from Oct 12, 2016 to Feb 12, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Low Feb 12, 2020

Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

FDA Devices Moderate Nov 13, 2019

Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for…

FDA Devices Moderate Nov 13, 2019

Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immu…

FDA Devices Low Oct 2, 2019

Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of ur…

FDA Devices Low Sep 18, 2019

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analy…

FDA Devices Moderate Jun 26, 2019

Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053

FDA Devices Moderate May 8, 2019

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 q…

FDA Devices Moderate May 8, 2019

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 th…

FDA Devices Low Apr 17, 2019

Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality…

FDA Devices Low Apr 17, 2019

Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed qua…

FDA Devices Low Apr 17, 2019

Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assaye…

FDA Devices Moderate Apr 3, 2019

Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro d…

FDA Devices Moderate Mar 27, 2019

Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…

FDA Devices Moderate Mar 27, 2019

Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…

FDA Devices Moderate Mar 27, 2019

Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…

FDA Devices Moderate Feb 27, 2019

Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

FDA Devices Moderate Feb 27, 2019

Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368

FDA Devices Moderate Jan 2, 2019

SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, Ig…

FDA Devices Moderate Nov 14, 2018

Liquid Cardiac Control, CQ5053

FDA Devices Moderate Nov 14, 2018

Liquid Cardiac Control, CQ5052

FDA Devices Moderate Nov 14, 2018

Liquid Cardiac Control, CQ5051

FDA Devices Moderate Aug 8, 2018

Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of …

FDA Devices Moderate Jul 4, 2018

Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

FDA Devices Moderate Jul 4, 2018

Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

FDA Devices Moderate Jul 4, 2018

Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

FDA Devices Moderate May 16, 2018

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the…

FDA Devices Moderate Jan 3, 2018

Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series ins…

FDA Devices Moderate Oct 26, 2016

Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and p…

FDA Devices Moderate Oct 12, 2016

IgE Calibrator Series

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.