Lower risk Medical device recall · FDA · Published March 5, 2024

Randox Clinical Chemistry Calibration Serum Recall: Inorganic Phosphate Bias Issue

Randox recalls Clinical Chemistry Calibration Serum (Cal2351) due to potential inorganic phosphate bias on RX Series instruments. Affected lots may cause inaccurate test results. Contact Randox for details.

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

🇺🇸 FDA recall #Z-1759-2024Medical device Randox ›

Lower-risk recall

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Randox is recalling a clinical chemistry calibration serum that may cause inaccurate test results on certain instruments. This affects labs using specific lots of the serum, which could lead to incorrect patient test results if not addressed. Read more at govinfonow.com/recall/55988-randox-clinical-chemistry-calibration-serum-recall-inorganic-phosphate-bias-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/55988-randox-clinical-chemistry-calibration-serum-recall-inorganic-phosphate-bias-issue · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1759-2024

Cite this page

“Randox Clinical Chemistry Calibration Serum Recall: Inorganic Phosphate Bias Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55988-randox-clinical-chemistry-calibration-serum-recall-inorganic-phosphate-bias-issue. Based on FDA recall #Z-1759-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1759-2024%22&limit=1).

The FDA announced on March 5, 2024, that Randox Laboratories Ltd. is recalling Clinical Chemistry Calibration Serum (Catalog number Cal2351) due to negative bias in Inorganic Phosphate levels. The agency classified the recall as Class II.

How to tell if you have it

Randox
Clinical Chemistry Calibration Serum
Cal2351
05055273200966
Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE
Nationwide Distribution

The hazard

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Context

GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Other recent recalls include the Randox Cystatin C Reagent Recall (June 7, 2024), the Randox Evidence MultiSTAT Software v3.7 Recall (April 5, 2024), and the Randox Liquid Protein Calibrators Recall (March 1, 2024). Other recent recalls of similar products include the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), the Siemens Dimension Creatinine Flex Reagent Cartridge Recall (March 18, 2026), and the Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026).

How to tell if you have this one

Check for the catalog number Cal2351 or Cal10388 on the serum container. Affected lots include 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, and 1326UE.

Brand
Randox
Product
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serum Lot Number
Look for the lot numbers 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, or 1326UE on the serum container.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Domestic: 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.

Mar 5, 2024Firm started the recall
May 3, 2024FDA classified it Class II
May 15, 2024Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/55988-randox-clinical-chemistry-calibration-serum-recall-inorganic-phosphate-bias-issue">Randox Clinical Chemistry Calibration Serum Recall: Inorganic Phosphate Bias Issue (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-1759-2024 (March 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1759-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.