Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of Recalled by Randox Laboratories Ltd. Due to Standard packed within NEFA kit has been assigned...
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
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Quantity: 71 kits US
Why Was This Recalled?
Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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