Soluble Transferrin Receptors Calibrator Series (STFR CAL)… recallZ-1423-2022 · Randox Laboratories Ltd. · initiated Jun 9, 2022

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
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Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On June 9, 2022, the firm notified customers of the recall via email. The issue only affects Siemens Atellica CH analyzer users. No action is required if the assay is being run on other platforms. The issue will be resolved in Atellica Solution Software (SW) version 1.25.3. Until all Atellica CH analyzers in the laboratory are updated to SW 1.25.3, the assay can be run by Open Channel. Please contact [email protected] for an Atellica CH Open Channel application sheet. If the assay is not run by Open Channel prior to installation of SW version 1.25.3, the assay must be re-calibrated once 1.25.3 is installed. Customers were instructed to review results generated with the affected batches in line with the clinical profile of the patient.

Recall details

Recall number: Z-1423-2022
Status: Terminated
Initiated by the company: Jun 9, 2022
Recalling firm: Randox Laboratories Ltd.
Quantity: 12 kits (US)
Product code: DDG
FDA submissions: K002585
Distribution: US Nationwide distribution in the state of IL.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI (GTIN): 05055273215557 All lots within expiry

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL) TF10161
Randox Laboratories Limited · Calibrator, Secondary
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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