Lower riskMedical device recall · FDA · Published August 3, 2023
Randox Liquid Assayed Chemistry Control Premium Plus Level 3: Incorrect IFU Values May
Randox recalls Liquid Assayed Chemistry Control Premium Plus Level 3 (LAE4215) due to incorrect Caeruloplasmin values in instructions. Most labs use target values safely, but misreporting risks patient errors.
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
“Randox Liquid Assayed Chemistry Control Premium Plus Level 3: Incorrect IFU Values May.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57549-randox-liquid-assayed-chemistry-control-premium-plus-level-3-incorrect. Based on FDA recall #Z-2609-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2609-2023%22&limit=1).
Randox Laboratories Ltd. voluntarily recalled Liquid Assayed Chemistry Control Premium Plus Level 3, catalog number LAE4215, due to a transcription error in the Instructions for Use that may lead to misreporting patient results, according to the FDA on Aug. 3, 2023.
How to tell if you have it
Brand: Randox
Product: Liquid Assayed Chemistry Control Premium Plus Level 3
Catalog Number: LAE4215
UDI-DI: 05055273208986
Lot Number: 1308UE
Quantity: 66 kits
Sold in: GA, OH, OR, PA, TX, VA
The hazard
The hazard is a transcription error in the Instructions for Use where the one and two standard deviation values for Caeruloplasmin are incorrect. This may lead to misreporting patient results, although target and range values remain correct.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Other recent recalls of similar products include Randox Cystatin C Reagent Recall (June 7, 2024), Randox Evidence MultiSTAT Software v3.7 Recall (April 5, 2024), and Randox Clinical Chemistry Calibration Serum Recall (March 5, 2024). Other recent recalls of similar products include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026).
How to tell if you have this one
Look for the product name 'Liquid Assayed Chemistry Control Premium Plus Level 3' with catalog number LAE4215. The lot number 1308UE is also associated with this recall.
Brand
Randox
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number LAE4215 and lot number 1308UE on the product label.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “US States: GA, OH, OR, PA, TX, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-2609-2023 (August 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2609-2023 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.