Randox Laboratories Ltd. recalls NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

Recall date

May 10, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2099-2021

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115