NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Recall Z-2099-2021 · Posted None
Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJLH
Date Initiated2021-05-10
Date Terminated2021-11-10
Product Quantity71 kits US
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
Firm Action
Randox notified the distribution center within the USA via email on 5/10/21.The distributor will then contact the customer directly.
Letter states reason for recall, health risk, and action to take:
Action to be taken:
" Please discard previous value sheets and ensure standard value is updated.
" Review results generated with the affected batches in line with the clinical profile of
the patient.
" Discuss the contents of this notice with your Medical Director
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.