Lower riskMedical device recall · FDA · Published November 1, 2021
Randox Cholesterol Test System Recall: Calibration Errors May Cause High Results
Randox recalls cholesterol test system (REF CH200) due to calibration errors causing high results. Affected lots from June 2022 to July 2023. No remedy stated in official notice.
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
“Randox Cholesterol Test System Recall: Calibration Errors May Cause High Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61613-randox-cholesterol-test-system-recall-calibration-errors-may-cause-high. Based on FDA recall #Z-0328-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0328-2022%22&limit=1).
The FDA announced on 2021-11-01 that Randox Laboratories Ltd. voluntarily recalled the RANDOX CHOL-cholesterol (total) test system due to calibration issues. The hazard involves internal quality control results falling outside the expected range. This Class II recall, identified by agency number Z-0328-2022, has been terminated.
How to tell if you have it
Brand: Randox
Product: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
UPC: 05055273201130
Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023
The hazard
According to the FDA, when calibrating using the standard provided in the kit, the change in absorbance is lower than expected. This generates internal quality control results high outside range.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Recent brand recalls include the 2024-06-07 Randox Cystatin C Reagent Recall for missing FDA 510(k) and the 2024-04-05 Randox Evidence MultiSTAT Software v3.7 Recall for light leak risk. Other recent recalls of similar products include the 2026-07-06 Siemens Atellica CH Urine Albumin Recall, the 2026-03-16 Beckman Coulter Access Total T4 Calibrator Recall, and the 2025-11-21 Roche Elecsys Anti-TSHR Assay Recall.
How to tell if you have this one
Check the lot number on the test system packaging. Affected lots are 559344 (expires 28 June 2022) or 572730 (expires 28 July 2023).
Brand
Randox
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for lot numbers 559344 or 572730 on the test system packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Oregon, Pennsylvania, Washington, West Virginia.
Recall timeline
FDA terminated this recall 16 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-0328-2022 (November 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0328-2022 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.