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

Recall Z-0215-2016 — Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310

U.S. FDA — Device Enforcement · France · 2015-09-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0215-2016
Date of alert
2015-09-22
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
ELITech Clinical Systems SAS
Product category
device
Product type
Devices
Reported risk: ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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