Lower riskMedical device recall · FDA · Published June 22, 2022
Randox Cholesterol Test Kits May Give Inaccurate Results
Randox recalls cholesterol test kits that may produce inaccurate results due to reduced linearity in calibration. Affected kits have specific catalog numbers and expiry dates. Consumers should contact Randox for guidance.
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
Randox is recalling cholesterol test kits that may give inaccurate results when used for quantitative cholesterol testing. This could lead to delayed results or incorrect health assessments if the kits are used without proper calibration. Read more at govinfonow.com/recall/60471-randox-cholesterol-test-kits-may-give-inaccurate-results.
“Randox Cholesterol Test Kits May Give Inaccurate Results.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60471-randox-cholesterol-test-kits-may-give-inaccurate-results. Based on FDA recall #Z-1424-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1424-2022%22&limit=1).
The FDA announced on June 22, 2022, that Randox Laboratories Ltd. voluntarily recalled Randox Cholesterol diagnostic kits due to performance failures that may lead to delayed results. The agency issued recall number Z-1424-2022 for the Class II device.
How to tell if you have it
Brand: Randox
Product: Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma
Catalog Number: CH2O0
UPC: 05055273201130
Lot Number: 586177
Expiry Date: 28th Jan 2024
The hazard
The product fails to meet performance claims, generating internal quality control results high outside range or reduced linearity. The FDA stated this may lead to delayed results.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Other recent recalls include the Randox Cystatin C Reagent Recall (June 7, 2024), the Randox Evidence MultiSTAT Software v3.7 Recall (April 5, 2024), and the Randox Clinical Chemistry Calibration Serum Recall (March 5, 2024). Other recent recalls of similar products include GET TESTED Cholesterol Test Recall (Nov. 3, 2025), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026).
How to tell if you have this one
Check for catalog number CH2O0 and expiry date January 28, 2024 on the test kit packaging. The kits are sold by Randox Laboratories Ltd. for home cholesterol testing.
Brand
Randox
Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for catalog number CH2O0 and expiry date January 28, 2024 on the test kit packaging.
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: “Nationwide Distribution - MD, OR, PR, MT, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, Montana, Oregon, Puerto Rico, West Virginia.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1424-2022 (June 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1424-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.