Randox Laboratories Ltd. recalls Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

Recall date

June 9, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1423-2022

FDA classification

Class III

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide distribution in the state of IL.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD