Rando: Randox recalls calibration serum (lot 961UE+) with potential 10% AST and 9% ALT errors affecting clinical tests. No remedy stated in official notice.
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).
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.
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.
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.
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.
Look for the lot number on the serum label; recalled lots are 961UE onwards.
No, this is a calibration error that could lead to inaccurate test results but does not pose a direct safety risk to users.
The official recall notice does not specify a remedy, so no action is required beyond checking the lot number.
The serum may have 10% higher AST and 9% higher ALT concentrations than intended, causing clinical chemistry tests to show inaccurate results.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2490-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-2490-2019 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
