Randox recalls Total Bilirubin test kits due to reports of inaccurate results with plasma samples. Affected kits include specific catalog numbers and all batches. No remedy is listed in the recall notice.
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Randox is recalling Total Bilirubin test kits because they've reported cases of inaccurate results when used with plasma samples. This could lead to incorrect blood test outcomes, which might affect medical decisions.
The test kits may produce elevated results when used with plasma samples containing lithium heparin. This could lead to incorrect blood test outcomes, potentially affecting medical decisions.
Healthcare providers and labs using Randox Total Bilirubin test kits are affected. Patients are at risk if their labs use the recalled kits for blood tests.
Check for catalog numbers BR8377, BR9766, or BR4061 on the kit. The GTINs are 05055273214772, 05055273208337, and 05055273214765. All batches of these kits are affected.
Look for catalog numbers BR8377, BR9766, or BR4061 on the kit label.
Randox has had reports of elevated patient results using plasma samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
The recall notice does not specify a remedy, so check the kit details and contact Randox for further guidance.
All batches of the recalled kits are affected, as indicated by the catalog numbers and GTINs listed.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0501-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0501-2024 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
