Medical device recalls

Randox Laboratories, Limited recalls RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

Recall date
September 23, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0367-2020
FDA classification
Class III
Brand / firm
Randox Laboratories, Limited
Sold / distributed
WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW

Why it was recalled

Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

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