FDA-Device2021-07-28Class II
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Randox Laboratories Ltd.
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
Sold states
US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Affected count
71 kits US
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2021Don't want to check this manually?
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