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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Randox Laboratories Ltd.: 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 o

Agency Publication Date: July 20, 2022
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Affected Products

Product: Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

UDI-DI (GTIN): 05055273215564 All lots within expiry

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

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90471
Status: Resolved
Manufacturer: Randox Laboratories Ltd.
Manufactured In: Ireland
Units Affected: 2 products (12 kits (US))

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.