Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Products Sold
Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115 due to Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with bot. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Randox notified the distribution center within the USA via email on 5/10/21.The distributor will then contact the customer directly. Letter states reason for recall, health risk, and action to take: Action to be taken: " Please discard previous value sheets and ensure standard value is updated. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026