Soluble Transferrin Receptors Calibrator Series — Class III medical device recall Z-1423-2022
Terminated recall by Randox Laboratories Ltd., reported 2022-07-27, distributed nationwide. A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigatio
| Recall number | Z-1423-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2022-06-09 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 12 kits |
| UPC / GTIN / UDI-DI | 05055273215557 |
| Model numbers | TF10161 |
Product
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.