FDA recall Z-0501-2024

Product

RANDOX Total Bilirubin.

Reason for recall

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

Distribution

US Nationwide distribution in the states of AR, GA, NC, TN, & PR.

Key facts

Status

Ongoing

Initiation date

2023-10-11

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2024