Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0501-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

RANDOX Total Bilirubin.

Product Classification:

Class II

Date Initiated: October 11, 2023

Date Posted: December 13, 2023

Recall Number: Z-0501-2024

Event ID: 93387

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1644 units

Code Information:

Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated