Lower risk Medical device recall · FDA · Published November 13, 2023

Randox Calibration Serums Have Transcription Errors in Instructions - Recall

Randox recalls Calibration Serum Level 3 (CAL 3) and Human Assayed Multi-Sera Level 2 (HN1530) due to transcription errors in instructions for bilirubin, triglycerides, and TBIC target values. Affected lots expire by November 2024 to May 2025.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0751-2024Medical device Randox ›

Lower-risk recall

There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.

Take action

Contact the company

Recalling firmRandox Laboratories Ltd.55 Diamond Road · Crumlin (North), Ireland

✎ GovInfoNow plain-language explainer

Randox is recalling specific calibration serum products because their instructions for use contain transcription errors for bilirubin, triglycerides, and TBIC target values. This could lead to incorrect test results if users follow the flawed instructions. Read more at govinfonow.com/recall/56876-randox-calibration-serums-have-transcription-errors-in-instructions-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/56876-randox-calibration-serums-have-transcription-errors-in-instructions-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0751-2024

Cite this page

“Randox Calibration Serums Have Transcription Errors in Instructions - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56876-randox-calibration-serums-have-transcription-errors-in-instructions-recall. Based on FDA recall #Z-0751-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0751-2024%22&limit=1).

The FDA announced on 2023-11-13 that Randox Laboratories Ltd. is recalling Calibration Serum Level 3 and Human Assayed Multi-Sera due to transcription errors in the Instructions For Use, according to the FDA.

How to tell if you have it

Brand: Randox
Product: Calibration Serum Level 3 (CAL 3), REF CAL2351
Product: Human Assayed Multi-Sera Level 2 (HN1530)
Product: Human Assayed Multi-Sera Level 3 (HE 1532)
Lot codes: 1260UE, 1262UE, 1315UE
Expiration dates: 28 Nov 2024, 28 Jan 2025, 28 May 2025
Distribution: US Nationwide

The hazard

There have been transcription errors on the Instructions For Use of the Calibration Serum Level 3 for target values of Bilirubin and Triglycerides, according to the FDA. Errors also appear on the IFU of Human Assayed Multi-Sera Level 2 for TBIC target value and on IFU of Human Assayed Multi-Sera Level 3 for Lipase target value.

Context

GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Other recent recalls include the Randox Cystatin C Reagent Recall (2024-06-07), the Randox Evidence MultiSTAT Software v3.7 Recall (2024-04-05), and the Randox Clinical Chemistry Calibration Serum Recall (2024-03-05). Other recent recalls of similar products include the Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18).

How to tell if you have this one

Check for the product names: Calibration Serum Level 3 (CAL 3, REF CAL2351) or Human Assayed Multi-Sera Level 2 (HN1530). The affected lots are 1260UE (expires Nov 2024), 1262UE (expires Jan 2025), and 1315UE (expires May 2025).

Brand
Randox
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Look for lot numbers 1260UE, 1262UE, or 1315UE on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Nov 13, 2023Firm started the recall
Jan 18, 2024FDA classified it Class II
Jan 24, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these products?

No, the recall is for the instructions, not the product itself. Users can continue using the products but should follow the corrected instructions from Randox.

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Link to this recall

<a href="https://govinfonow.com/recall/56876-randox-calibration-serums-have-transcription-errors-in-instructions-recall">Randox Calibration Serums Have Transcription Errors in Instructions - Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0751-2024 (November 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0751-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.