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ELITech Clinical Systems SAS recalls ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method.
Recalled November 11, 2015 · FDA recall Z-0216-2016 · ELITech Clinical Systems SAS
Hazard
ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received. · FDA Class II
Units
969 systems
Sold at
US Nationwide Distribution
Description
ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.
Product
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G
Manufacturer(s)
ELITech Clinical Systems SAS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →