Lower riskMedical device recall · FDA · Published June 21, 2023
Randox Urine Control Level 2 Recall: Incorrect Results Risk Delayed Patient Care
Randox recalls urine control kits with potential for incorrect hCG and cortisol results, causing delays in patient testing. Affected kits may have vial variations or transcription errors in instructions.
(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.
“Randox Urine Control Level 2 Recall: Incorrect Results Risk Delayed Patient Care.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57826-randox-urine-control-level-2-recall-incorrect-results-risk-delayed. Based on FDA recall #Z-2446-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2446-2023%22&limit=1).
Randox Laboratories Ltd. recalled Randox Liquid Urine Control Level 2- on June 21, 2023, according to the FDA. The product may yield inaccurate test results due to vial-to-vial variation and transcription errors. Owners should contact the company for a refund.
How to tell if you have it
Brand: Randox
Product: Randox Liquid Urine Control Level 2-
Catalog Number: UC5074
GTIN/UPC: 05055273207569
Lot Code: 1209UC
Expiry Date: 28 Mar 24
The hazard
The FDA stated that some vials may recover positive for hCG when they should be negative, and cortisol levels may be high and outside range. Additionally, there is a transcription error in the Instructions For Use regarding Creatinine target ranges for the Roche Creatinine Plus method. These failures cause a delay in patient results.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a June 7, 2024 recall for missing FDA 510(k) clearance and an April 5, 2024 recall for light leak risks in software. Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips (Nov. 22, 2025), Siemens Atellica CH Urine Albumin (July 6, 2026), and Menopause Test Cassette (Nov. 22, 2025).
How to tell if you have this one
Check for the catalog number UC5074 or GTIN 05055273207569 on the kit. The batch number starts with 1209UC and expires by March 28, 2024.
Brand
Randox
Product
Randox Liquid Urine Control Level 2
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the catalog number UC5074 or GTIN 05055273207569 on the kit label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, Florida, Georgia, Ohio, Virginia.
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-2446-2023 (June 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2446-2023 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.