medical Class II Updated 2018-08-08

ELITech Clinical Systems SAS recalls ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: U.S. only. No gov. accounts. No international.
Lot/Code Info: Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019
View official government recall

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