ELITech Clinical Systems SAS recalls Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference…

Recall date

September 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0215-2016

FDA classification

Class II

Brand / firm

ELITech Clinical Systems SAS

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 Cholesterol, LDL (LDLL)