FDA recall Z-2591-2018

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

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

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

Key facts

Status

Terminated

Initiation date

2017-04-18

Report date

2018-08-08

Termination date

2020-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sees, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2018