PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: November 20, 2019 Initiated: September 23, 2019 #Z-0367-2020

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.

Details

Units Affected
212 (19 US; 193 OUS)
Distribution
WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW
Location
Crumlin, N/A

Frequently Asked Questions

What product was recalled?
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.. Recalled by Randox Laboratories, Limited. Units affected: 212 (19 US; 193 OUS).
Why was this product recalled?
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 20, 2019. Severity: Low. Recall number: Z-0367-2020.