Lower riskMedical device recall · FDA · Published October 11, 2023
Randox Total Bilirubin: Elevated Patient Results Risk
Randox recalls Total Bilirubin test kits due to reports of inaccurate results with plasma samples. Affected kits include specific catalog numbers and all batches. No remedy is listed in the recall notice.
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
“Randox Total Bilirubin: Elevated Patient Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57101-randox-total-bilirubin-elevated-patient-results-risk. Based on FDA recall #Z-0501-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0501-2024%22&limit=1).
Randox Laboratories Ltd. voluntarily recalled RANDOX Total Bilirubin reagent on Oct. 11, 2023, after reports of elevated patient results using plasma samples, according to the FDA. The Food and Drug Administration announced the Class II recall under agency number Z-0501-2024.
Randox has received reports of elevated patient results when using Plasma (lithium heparin) samples with the Total Bilirubin reagent (TBil) Vanadate Oxidation Method, according to the FDA.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a Cystatin C Reagent recall on June 7, 2024, for missing FDA 510(k) clearance and an Evidence MultiSTAT Software v3.7 recall on April 5, 2024, due to light leak risks. Other recent recalls of similar products include a Beckman Coulter DxH Diluent recall on Nov. 10, 2025, and Siemens Dimension Tacrolimus Flex Reagent Cartridge recall on May 7, 2026.
How to tell if you have this one
Check for catalog numbers BR8377, BR9766, or BR4061 on the kit. The GTINs are 05055273214772, 05055273208337, and 05055273214765. All batches of these kits are affected.
Brand
Randox
Product
RANDOX Total Bilirubin
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for catalog numbers BR8377, BR9766, or BR4061 on the kit label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AR, GA, NC, TN, & PR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, Georgia, North Carolina, Puerto Rico, Tennessee.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0501-2024 (October 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0501-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.