Randox recalls STFR reagents for research use only due to calibration issues with Siemens Atellica analyzers causing non-numerical results in low concentration ranges. Affected lots reported.
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in non-numerical results. This affects Siemens Atellica CH analysers only. Customer have reported an atypical calibration curve that results in the values around the low QC range to produce a non-numerical result. It appears to be related to the bottle values of the calibrator producing a curve shape that is too linear for the logitlog calculation to calculate. This issue can only be identified in the Atellica graphical view of the calibration. In most of the cases when this has occurred, it is picked up by the QC generating a Math Error, however, there are reports of QC shifts after calibration without the Math Error flagged that may be related to this issue. Results reported with STFR Level 1, with a concentration less than 1.7mg/L, using TF10159 and TF10161 can be underestimated by up to 30%. This issue has been reported with reagent lots 575475 and 562691, calibrator lots 537725 and 562696. No other complaints received.
Randox is recalling Soluble Transferrin Receptors (STFR) reagents for research use only because they can cause non-numerical results on Siemens Atellica analyzers when concentrations are below 1.7mg/L. This issue affects specific reagent and calibrator lots that were sold with the product.
The reagent's calibrator bottle values create a calibration curve that is too linear for the logitlog calculation, causing non-numerical results in low concentration ranges (below 1.7mg/L). This issue is only visible in the Atellica's graphical calibration view and may not trigger a QC math error in some cases.
Researchers using Siemens Atellica CH analyzers with Randox STFR reagents (catalog TF10159) and specific lots (575475, 562691 for reagents; 537725, 562696 for calibrators) are affected. The risk is low as most cases are caught by QC checks.
Check if you have Soluble Transferrin Receptors (STFR) reagent catalog TF10159 (Research Use Only) with lot numbers 575475 or 562691, or calibrator lot numbers 537725 or 562696. The product is sold for research use only and has a GTIN of 05055273215564.
Identify if your STFR reagent has lot numbers 575475 or 562691, or calibrator lot numbers 537725 or 562696.
Randox confirmed that specific lots of STFR reagents and calibrators cause atypical calibration curves on Siemens Atellica analyzers, leading to non-numerical results in low concentration ranges.
Results for STFR Level 1 with concentrations below 1.7mg/L using affected lots can be underestimated by up to 30%.
The recall record does not specify a remedy; the issue is identified through the Atellica's graphical calibration view.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1422-2022 — Randox Randox Hello, I own a Randox that is covered by recall Z-1422-2022 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.
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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.
