Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Liquid Assayed Chemistry Control Premium Plus Level 3 Recalled by Randox Laboratories Ltd. Due to there has been a transcription error in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories Ltd. directly.
Affected Products
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Quantity: 66 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 6 states: GA, OH, OR, PA, TX, VA
About Randox Laboratories Ltd.
Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report