Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Check against the official notice below — it lists the full affected range.
Randox Laboratories recalled Soluble Transferrin Receptors Calibrator Series (STFR CAL, catalog number TF10161) after a customer reported problems with the reagent and calibrator that produces atypical calibration curves. The issue affects only Siemens Atellica CH analysers and occurs when calibrator bottle values produce a curve shape too linear for proper calculation. Results with STFR Level 1 concentrations below 1.7mg/L using reagent lots 575475 and 562691 or calibrator lots 537725 and 562696 can be underestimated by up to 30 percent. Most cases generate a Math Error flag during quality control checks, though some quality control shifts after calibration have occurred without this error flag. Twelve kits were distributed nationwide in Illinois.
The source does not specify a remedy or corrective action for affected consumers.
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): 05055273215557 All lots within expiry
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.