Device product
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Z-0367-2020
Product summary
- Event
- Event 84007
- Status
- Terminated
- Classification
- Class III
- Quantity
- 212 (19 US; 193 OUS)
- Official record key
device-enforcement:Z-0367-2020
Official wording
Reason: Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
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
Derived failure modes
-
Unknown
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.