Home / Recalls / Randox Laboratories, Limited / Z-0367-2020

Z-0367-2020 Class III Terminated

Recalled by Randox Laboratories, Limited — Crumlin, N/A

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
September 23, 2019
Termination Date
May 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
212 (19 US; 193 OUS)

Product Description

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 Pattern

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

Code Information

Catalogue number: FA115 GTIN: 05055273203066 Batch/Lot: 485343 Exp: Mar 2019

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