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ELITech Clinical Systems SAS recalls Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Refe
Recalled November 11, 2015 · FDA recall Z-0214-2016 · ELITech Clinical Systems SAS
Hazard
ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received. · FDA Class II
Units
1389 systems
Sold at
US Nationwide Distribution
Description
ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.
Product
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- 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 →