Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2099-2021 — NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

U.S. FDA — Device Enforcement · Ireland · 2021-05-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2099-2021
Date of alert
2021-05-10
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273203066
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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