Randox Laboratories, Limited: Medical Device Recall in 2019 - (Recall #: Z-0367-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: September 23, 2019

Date Posted: November 20, 2019

Recall Number: Z-0367-2020

Event ID: 84007

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.

Status: Terminated

Product Quantity: 212 (19 US; 193 OUS)

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated