Z-0367-2020 Class III Terminated
FDA device recall Z-0367-2020 was initiated by Randox Laboratories, Limited on September 23, 2019 and is designated Class III. 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. The recall status is terminated (terminated May 7, 2020). Affected quantity: 212 (19 US; 193 OUS).
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