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FDAMay 10, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273203066

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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