Randox Laboratories Ltd. is recalling approximately 115 kits of the RX Series Cystatin C Reagent, which is used in automated diagnostic machines to test kidney function. This recall was initiated because the product was marketed and distributed in the United States without the required FDA 510(k) clearance, which is the process used to demonstrate that a medical device is safe and effective. Consumers and labs using this diagnostic tool should be aware that the manufacturer has voluntarily recalled all lots of this specific reagent (Catalogue Number CYS4004). Because this is a medical device issue, users should contact their healthcare provider or the manufacturer directly regarding any concerns with test results.
The reagent was marketed without undergoing the required FDA regulatory review to ensure its safety and effectiveness for diagnostic use. While no specific injuries have been reported, using an unvetted diagnostic tool could lead to inaccurate test results, potentially affecting clinical decisions regarding a patient's kidney health.
Regulatory non-compliance correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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.