Lower risk Medical device recall · FDA · Published March 29, 2021

Randox Calibration Serum Level 3 (CAL 3) recall: Positive bias in bilirubin tests

Randox recalls Calibration Serum Level 3 (CAL 3) with batch 1162UE due to potential positive bias in bilirubin tests. Affected users should check their batch numbers and contact Randox for guidance.

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

🇺🇸 FDA recall #Z-1563-2021Medical device Randox ›

Lower-risk recall

Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Randox is recalling Calibration Serum Level 3 (CAL 3) with batch number 1162UE because it can cause bilirubin test results to be up to 15% higher than actual. This may lead to inaccurate medical diagnoses if used in patient testing. Read more at govinfonow.com/recall/62892-randox-calibration-serum-level-3-cal-3-recall-positive-bias.

Source Summary by GovInfoNow · govinfonow.com/recall/62892-randox-calibration-serum-level-3-cal-3-recall-positive-bias · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1563-2021

Cite this page

“Randox Calibration Serum Level 3 (CAL 3) recall: Positive bias in bilirubin tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62892-randox-calibration-serum-level-3-cal-3-recall-positive-bias. Based on FDA recall #Z-1563-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1563-2021%22&limit=1).

The FDA announced on March 29, 2021, that Randox Laboratories Ltd. recalled Calibration Serum Level 3 (CAL 3) due to a positive bias in Total and Direct Bilirubin results. The agency issued recall number Z-1563-2021 for the Class II device.

How to tell if you have it

Brand: Randox
Product: Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator
Catalogue Number: CAL2351
Lot number: 1162UE
UPC: 05055273200966

The hazard

The calibrator exhibits a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across assay ranges, attributed to bilirubin instability. This error is evident in both Quality Control and Patient samples.

Context

GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a March 5, 2024 recall for Inorganic Phosphate Bias in Calibration Serum and a June 7, 2024 recall regarding missing FDA 510(k) clearance for Cystatin C Reagent. Other recent recalls of similar products include the Siemens Atellica CH Urine Albumin recall (July 6, 2026), the Siemens Dimension Tacrolimus Flex Reagent Cartridge recall (May 7, 2026), and the Beckman Coulter Access Total T4 Calibrator recall (March 16, 2026).

How to tell if you have this one

Check for the batch number 1162UE on the Calibration Serum Level 3 (CAL 3) product. The product has catalogue number CAL2351 and GTIN 05055273200966.

Brand
Randox
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Batch Number
Look for the batch number 1162UE on the Calibration Serum Level 3 (CAL 3) product.

Where it went and when

Where it was distributed

Distributed in 14 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Connecticut, District of Columbia, Illinois, Indiana, Maryland, Massachusetts, Minnesota, Mississippi, Nebraska, New Jersey, New York, Oregon, Puerto Rico, Texas, Virginia.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Mar 29, 2021Firm started the recall
May 12, 2021FDA classified it Class II
May 19, 2021Published in FDA’s Enforcement Report
Nov 22, 2021FDA terminated the recall

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/62892-randox-calibration-serum-level-3-cal-3-recall-positive-bias">Randox Calibration Serum Level 3 (CAL 3) recall: Positive bias in bilirubin tests (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-1563-2021 (March 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1563-2021 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.