Recall Z-0501-2024

Reason for recall

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

FDA-determined cause: Device Design

Action taken

Consignees were emailed an Urgent Device Correction letter on 10/11/2023. The notice instructed consignees to only use Total Bilirubin Vanadate Oxidation Method on Serum samples, to review results generated with Plasma samples in like with the clinical profiles of the patient, discuss the contents of the recall notice with your facility's Medical Director, and to return the provided response form completed to technical.services@randox.com within 5 working days. The recall notice is to be further distributed to all affected customers and those within consignee organizations, if further distributed. A second recall notification, dated 4/26/24, was sent to consignees identifying the reason for the product issue to be intralipid interference. Reagent IFUs have been updated with sample specific Plasma (lithium heparin) interference claims for intralipids, which can be found on www.randox.com. Consignees are asked to complete and return the provided response form to technical.services@randox.com within five working days.