Randox Laboratories Ltd. is recalling 1,644 units of Total Bilirubin (TBil) reagent kits used in medical diagnostic testing. These kits, used with the Vanadate Oxidation Method on lithium heparin plasma samples, have been reported to produce incorrectly high patient results. Because clinicians rely on these tests to monitor liver function and gallbladder health, inaccurate results could lead to improper medical diagnoses or treatment decisions. These products were distributed to labs and healthcare facilities in Arkansas, Georgia, North Carolina, Tennessee, and Puerto Rico.
The reagent may provide falsely elevated bilirubin readings when testing certain plasma samples, which could cause medical providers to misdiagnose conditions or provide unnecessary treatment for liver or blood disorders. While no specific injuries were detailed in the report, diagnostic errors in clinical settings present a moderate risk to patient safety.
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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.
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Sources: FDA iRES · Raw API Response
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