Recall – Chemistry Analyzer

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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Partners located in the US (CA, FL, MA, MN) and Italy.