FDAApril 18, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

elitech clinical systems saselitechelitech clinical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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