medical Class II Updated 2021-07-28

Randox Laboratories Ltd. recalls NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for meas

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
View official government recall

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