FDA-Device2019-11-20Class III
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Randox Laboratories, Limited
Hazard
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
Sold states
WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW
Affected count
212 (19 US; 193 OUS)
Manufactured in
Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, United Kingdom
Products
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0367-2020Don't want to check this manually?
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