ELITech Clinical Systems SAS recalls ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method.…

Recall date

September 22, 2015

Source

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

Recall number

Z-0216-2016

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 Selectra ProS and ProM systems 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

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