NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is recalling NEFA CAL (Non-Esterified Fatty Acids) IVD Standard, Catalog Number FA115, Batch Number 544642, with an expiration date of November 28, 2022. The standard included in the kit was assigned an incorrect value, which means that laboratories using this kit to calibrate their equipment will obtain measurement results that are artificially high by up to 8 percent for both quality control samples and patient samples. The affected kits were distributed nationwide in Arkansas, California, Connecticut, New York, Ohio, Pennsylvania, Tennessee, and Texas, with 71 kits recalled in total.
The recall record does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX Quantity: 71 kits US Lot/code info: Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.