FDA recall Z-0367-2020

Product

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

Reason for recall

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

Distribution

WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW

Key facts

Status

Terminated

Initiation date

2019-09-23

Report date

2019-11-20

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0367-2020