Home / Recalls / ELITech Clinical Systems SAS / Z-2591-2018

Z-2591-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
August 8, 2018
Initiation Date
April 18, 2017
Termination Date
April 17, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

Reason for Recall

ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.

Distribution Pattern

U.S. only. No gov. accounts. No international.

Code Information

Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019

Other recalls by ELITech Clinical Systems SAS

  • 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-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)