---
title: "Randox Laboratories, Limited Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall"
description: "Search Randox Laboratories, Limited recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions."
url: https://isitonrecall.com/brand/randox-laboratories-limited/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Home](https://isitonrecall.com/) / Brand archive

# Randox Laboratories, Limited recall records

**2** reported ongoing

2 records in this archive. Latest source date Dec 20, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## Records and reported status

Dec 20, 2024 FDA device enforcement

### [Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403](https://isitonrecall.com/recall/fda-device-z-1017-2025-randox-lipoprotein-a-in-vitro-diagnostic-ivd-use-as-randox-lipoprotein-a-assay-on-automated-analyser/)

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Class II Reported ongoing

Distribution: US Nationwide distribution Including PR.

[Official source for Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automat...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1017-2025%22)

Dec 20, 2024 FDA device enforcement

### [Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757](https://isitonrecall.com/recall/fda-device-z-1018-2025-randox-lipoprotein-a-in-vitro-diagnostic-ivd-use-as-randox-lipoprotein-a-assay-on-automated-analyser/)

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Class II Reported ongoing

Distribution: US Nationwide distribution Including PR.

[Official source for Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automat...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1018-2025%22)

## Reasons in these listed records

- Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

These examples come from this result page and are not a ranking of every recall reason.

## Checking Randox Laboratories, Limited

### Is there a recall on randox laboratories, limited right now?

This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

### How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier.

### Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

### What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices.

### Where can I find older records?

Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

## Keep checking

[Search Randox Laboratories, Limited](https://isitonrecall.com/check/?q=Randox%20Laboratories%2C%20Limited) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)
