FDA-Device2015-11-11Class II
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)
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.
Sold states
US Nationwide Distribution
Affected count
612 total
Manufactured in
Zone lndustrielle, N/A, SEES, N/A, France
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0215-2016Don't want to check this manually?
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