# FDA recall Z-1422-2022

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2022-06-09.

## Product

Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). 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 underes

## Distribution

US Nationwide distribution in the state of IL.

## Key facts

- **Recall number:** Z-1422-2022
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-09
- **Report date:** 2022-07-27
- **Termination date:** 2024-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1422-2022

## Citation

> AI Analytics. FDA recall Z-1422-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1422-2022. Source: US FDA. Licensed CC0.

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