Lower riskMedical device recall · FDA · Published June 9, 2022
Randox Soluble Transferrin Receptors (STFR) Recall: Atypical Calibration Curves Cause
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 Soluble Transferrin Receptors (STFR) Recall: Atypical Calibration Curves Cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60519-randox-soluble-transferrin-receptors-stfr-recall-atypical-calibration-curves-cause. Based on FDA recall #Z-1422-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1422-2022%22&limit=1).
The FDA announced on June 9, 2022, that Randox Laboratories Ltd. is recalling Soluble Transferrin Receptors (STFR), Catalog Number TF10159, due to atypical calibration curves that can produce non-numerical results or underestimate values by up to 30%. The agency classified the recall as Class III.
How to tell if you have it
Brand: Randox
Product: Soluble Transferrin Receptors (STFR), Catalog Number TF10159
Lot codes: 575475, 562691 (reagent); 537725, 562696 (calibrator)
Distribution: US Nationwide distribution in the state of IL
The hazard
A customer reported atypical calibration curves that result in non-numerical results or values around the low QC range producing a non-numerical output. 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 affects Siemens Atellica CH analysers only.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Other recent recalls of similar products include Randox Cystatin C Reagent Recall (June 7, 2024), Randox Evidence MultiSTAT Software v3.7 Recall (April 5, 2024), and Randox Clinical Chemistry Calibration Serum Recall (March 5, 2024). Other recent recalls of similar products include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), and Diagnostica Stago STA Staclot Protein S Recall (July 29, 2026).
How to tell if you have this one
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.
Brand
Randox
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
US Nationwide distribution in the state of IL.
Recall number
Product, codes & lots
Z-1422-2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD; UDI-DI (GTIN): 05055273215564 All lots within expiry
Z-1423-2022
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD; UDI-DI (GTIN): 05055273215557 All lots within expiry
Based on the official FDA remedy
What to do — step by step
Check Product Lot Numbers
Identify if your STFR reagent has lot numbers 575475 or 562691, or calibrator lot numbers 537725 or 562696.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1422-2022 (June 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1422-2022 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.