Recall Z-0367-2020— Randox Laboratories, Limited

Name: FDA recall Z-0367-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-23

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories, Limited, initiated 2019-09-23, terminated 2020-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.. Reason: Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing..

Recalling firm: Randox Laboratories, Limited
Classification: Class III
Status: Terminated
Initiated: 2019-09-23
Terminated: 2020-05-07
Firm location: Crumlin, N/A, United Kingdom

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.