Home / Recalls / ELITech Clinical Systems SAS / Z-0217-2016

Z-0217-2016 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
13455 systems

Product Description

Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT

Reason for Recall

ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system 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-0214-2016 Class II — Eon 100 system included the following product reference numbers and names: Re (September 22, 2015)
  • Z-0216-2016 Class II — ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems tha (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)