FDA-Device2018-08-08Class II
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
ELITech Clinical Systems SAS
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.
Sold states
U.S. only. No gov. accounts. No international.
Affected count
N/A
Manufactured in
Zone Industrielle des Fourneaux, N/A, Sees, N/A, France
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2018Don't want to check this manually?
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