Laboratory Reagent Recalled Due to Inaccurate Calibration Curves
Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class III FDA recall with no reported illnesses or injuries. The hazard involves potential inaccuracy in laboratory test results (up to 30% underestimation in specific concentration ranges), which could affect clinical interpretation. However, the issue is limited to specific analyzer models and lot numbers, is often detected by quality control procedures, and has resulted in no complaints beyond the initial customer report.
Plain-English summary
Randox Laboratories Ltd. is recalling Soluble Transferrin Receptors (STFR), Catalog Number TF10159, a clinical laboratory test reagent. The recall affects 12 kits distributed in Illinois. Affected lots include reagent lots 575475 and 562691, and calibrator lots 537725 and 562696, all currently within their expiration dates.
The recall was initiated following a customer report of a defect in the reagent and calibrator formulation. The defect causes atypical calibration curves when used with Siemens Atellica CH analyzers specifically. The calibrator values produce overly linear curves that prevent the analyzer's logit-log calculation from functioning properly, resulting in either non-numerical results or inaccurate test values. For samples with STFR Level 1 concentrations below 1.7 mg/L, results can be underestimated by up to 30%. While most instances are detected through quality control checks that flag a Math Error, some quality control shifts after calibration have occurred without the Math Error flag.
This recall affects clinical laboratories using the specified reagent and calibrator lots with Siemens Atellica CH analyzers. No other complaints have been received beyond the initial customer report. Affected laboratories should immediately stop using the recalled lot numbers. Laboratory personnel should contact Randox Laboratories for replacement reagent and guidance on how to manage any previously reported results that may have been affected by this defect.
The recalled product
- Product
- Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). 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): 05055273215564 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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