Home / Recalls / ELITech Clinical Systems SAS / Z-0216-2016

Z-0216-2016 Class II Terminated

Recalled by ELITech Clinical Systems SAS — SEES, N/A

Recall Details

Product Type
Devices
Report Date
November 11, 2015
Initiation Date
September 22, 2015
Termination Date
March 4, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
969 systems

Product Description

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

Reason for Recall

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.

Distribution Pattern

US Nationwide Distribution

Code Information

all lots

Other recalls by ELITech Clinical Systems SAS

  • Z-2591-2018 Class II — ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator Hi (April 18, 2017)
  • Z-0217-2016 Class II — Envoy 500 system includes the following product reference numbers and names: (September 22, 2015)
  • Z-0214-2016 Class II — Eon 100 system included the following product reference numbers and names: Re (September 22, 2015)
  • Z-0215-2016 Class II — Eon 300 system includes the following product reference numbers and names: Re (September 22, 2015)
  • Z-0006-2015 Class III — ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. I (August 11, 2014)