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ELITech Clinical Systems SAS recalls Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Refere
Recalled November 11, 2015 · FDA recall Z-0215-2016 · ELITech Clinical Systems SAS
Hazard
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. · FDA Class II
Units
612 total
Sold at
US Nationwide Distribution
Description
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.
Product
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)
Manufacturer(s)
ELITech Clinical Systems SAS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →