FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: RANDOX Total Bilirubin.
- Recall number
- Z-0501-2024
- Recalling firm
- Randox Laboratories Ltd.
- Product
- RANDOX Total Bilirubin.
- Status
- Open, Classified
- Initiated
- 2023-10-11
- Posted
- 2023-12-06
- Terminated
- not on file
- Reason
- Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 1644 units
- Distribution
- US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
- Lot, serial or model codes
- Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.
- 510(k) numbers
- ["K152344"]
- PMA numbers
- not on file
- Product code
- JFM
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28