Randox Laboratories has recalled 48 kits of its Lipoprotein (a) assays, which are used as diagnostic tests on automated laboratory analyzers. The recall was issued because the specific use of these tests on Roche Cobas c501 analyzers with certain measurement claims does not have the required FDA clearance or approval. The affected products include catalog numbers LP3403 and LP2757 for all lots that have not yet expired. No incidents or injuries have been reported at this time.
The use of medical diagnostic tools without the required regulatory review means the accuracy and performance of the tests have not been verified by the FDA for these specific uses. This could potentially lead to incorrect laboratory results, which may affect clinical decisions made by healthcare providers.
Used on Roche Cobas c501 with nmol/l claims.
Used on Roche Cobas c501 with nmol/l claims.
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
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