FDA recall Z-2099-2021

Product

NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

Reason for recall

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

Distribution

US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX

Key facts

Status

Terminated

Initiation date

2021-05-10

Report date

2021-07-28

Termination date

2021-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2021