Device product
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Z-2099-2021
Product summary
- Event
- Event 88130
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71 kits US
- Official record key
device-enforcement:Z-2099-2021
Official wording
Reason: Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
Code information: Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Distribution pattern: US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Derived failure modes
-
Unknown
Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples