Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is recalling Soluble Transferrin Receptors (STFR) reagent and calibrator, catalog number TF10159, a research-use-only product distributed nationwide in Illinois. A customer reported a problem with atypical calibration curves that produce non-numerical results when used with Siemens Atellica CH analyzers. The issue stems from calibrator bottle values creating a curve shape too linear for proper calculation. While the problem is usually detected when quality control generates a Math Error, some cases show quality control shifts after calibration without this error flag. Results for STFR Level 1 samples with concentrations below 1.7mg/L may be underestimated by up to 30 percent. The affected reagent lots are 575475 and 562691, and the affected calibrator lots are 537725 and 562696. Twelve kits were distributed in the United States, and no other complaints have been received.
The recall document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution in the state of IL. Quantity: 12 kits (US) Lot/code info: UDI-DI (GTIN): 05055273215564 All lots within expiry
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.