Randox Calibration Serum Recall: 10% AST/9% ALT Calibration Error
Rando: Randox recalls calibration serum (lot 961UE+) with potential 10% AST and 9% ALT errors affecting clinical tests. No remedy stated in official notice.
Lower-risk recall
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Contact the company
What happened, in plain English
Randox recalls calibration serum for clinical chemistry tests due to potential 10% error in AST and 9% error in ALT measurements. This could lead to inaccurate test results if used without correction. Read more at govinfonow.com/recall/67431-randox-calibration-serum-recall-10-ast-9-alt-calibration-error.
Source Summary by GovInfoNow · govinfonow.com/recall/67431-randox-calibration-serum-recall-10-ast-9-alt-calibration-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2490-2019
Cite this page
“Randox Calibration Serum Recall: 10% AST/9% ALT Calibration Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67431-randox-calibration-serum-recall-10-ast-9-alt-calibration-error. Based on FDA recall #Z-2490-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2490-2019%22&limit=1).
Why it’s dangerous
The calibration serum may have 10% higher AST and 9% higher ALT concentrations than intended, causing clinical chemistry tests to show inaccurate results. This error occurs because the serum was realigned by 10% for AST and 9% for ALT to match the Mean of All Instrument method target.
Who’s affected
Healthcare professionals using Randox calibration serum for clinical chemistry tests. Those using the serum without proper calibration adjustments are at risk of inaccurate test results.
How to tell if you have this one
Check the lot number on the serum label. Recalled lots are 961UE and later (GTN: 05055273200966). This product is used in clinical chemistry labs for calibration.
- Brand
Randox- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the serum label; recalled lots are 961UE onwards.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-2490-2019 (July 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2490-2019 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.