Company: ELITech Clinical Systems SAS
Date of Enforcement Report: 8/8/2018
Class II:
PRODUCT
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
Recall Number: Z-2591-2018
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
RECALLING FIRM/MANUFACTURER
ELITech Clinical Systems SAS, Sees, France on 4/18/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
DISTRIBUTION
Nationwide