Randox Chemistry QC Premium Plus: Incorrect Sodium Control Target Risk
Randox recalls Chemistry QC Premium Plus (LAL4213) due to incorrect sodium control target values for in vitro diagnostics. This may affect lab accuracy in diagnostic testing.
Lower-risk recall
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Contact the company
What happened, in plain English
Randox is recalling its Chemistry QC Premium Plus test kits because the sodium control target values are incorrectly set. This could lead to inaccurate lab results if used in diagnostic testing. Read more at govinfonow.com/recall/65815-randox-chemistry-qc-premium-plus-incorrect-sodium-control-target-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/65815-randox-chemistry-qc-premium-plus-incorrect-sodium-control-target-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1547-2020
Cite this page
“Randox Chemistry QC Premium Plus: Incorrect Sodium Control Target Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65815-randox-chemistry-qc-premium-plus-incorrect-sodium-control-target-risk. Based on FDA recall #Z-1547-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1547-2020%22&limit=1).
Why it’s dangerous
The sodium control target values are set incorrectly for the indirect ISE method. This could cause inaccurate test results if the control kit is used in diagnostic quality control processes.
Who’s affected
Lab technicians and healthcare facilities using this product for in vitro diagnostic testing. Those using the control kit for quality assurance in diagnostic labs are most at risk.
How to tell if you have this one
Check for the product name 'Chemistry QC Premium Plus', catalog number LAL4213, and GTIN 05055273209006. The recall applies to lot 306UL.
- Brand
Randox- Product
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006- Category
Medical device
What to do — step by step
Check Product Details
Verify the catalog number (LAL4213) and GTIN (05055273209006) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Delaware, Idaho, Indiana, Puerto Rico, Virginia, West Virginia.
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1547-2020 (February 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1547-2020 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.