Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III device recall with no reported illnesses, injuries, or deaths. The hazard is confirmed but unconfirmed to have caused patient harm. Class III recalls with real but unconfirmed clinical impact are typically scored as Moderate.
Plain-English summary
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161, an in vitro diagnostic device used to calibrate clinical laboratory analyzers. The affected calibrators include reagent lots 575475 and 562691, and calibrator lots 537725 and 562696, distributed in Illinois.
The calibrators can produce atypical calibration curves that result in incorrect calculations for Siemens Atellica CH laboratory analyzers. The calibrator bottle values create curves that are too linear for the logitlog calculation function, potentially resulting in non-numerical results or inaccurate values. When testing samples with Soluble Transferrin Receptor Level 1 at concentrations below 1.7 mg/L, results can be underestimated by up to 30 percent.
Laboratory facilities using the affected calibrators with Siemens Atellica CH analyzers are at risk. In many cases, the quality control process flags a Math Error, but some cases show quality control shifts without this error flagged, which may be related to the calibration issue. Users should verify whether their reagent and calibrator lots match the recalled numbers and contact Randox Laboratories or their distributor for instructions on replacement or verification. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI (GTIN): 05055273215557 All lots within expiry
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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