Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.
- Recall date
- October 11, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0501-2024
- FDA classification
- Class II
- Brand / firm
- Randox Laboratories Ltd.
- Sold / distributed
- US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Why it was recalled
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RANDOX Total Bilirubin.
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