FDA-Device2023-12-13Class II
RANDOX Total Bilirubin.
Randox Laboratories Ltd.
Hazard
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Sold states
US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Affected count
1644 units
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
RANDOX Total Bilirubin.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief