Home / Recalls / Medical Devices
Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.
Recalled December 13, 2023 · FDA recall Z-0501-2024 · Randox Laboratories
Hazard
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. · FDA Class II
Units
1644 units
Sold at
US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Description
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Product
RANDOX Total Bilirubin.
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →