Sees, N/A, France
ELITech Clinical Systems SAS recalls
1 recall recorded since 2018, most recently on 18 April 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 April 2017
- Terminated
- 17 April 2020
- Reason
- 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
- U.S. only. No gov. accounts. No international.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2591-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.