NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
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 You Should Do
Remedy
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
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Products
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
- UPC
- Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Units Affected
71 kits US