# FDA recall Z-2591-2018

> **ELITech Clinical Systems SAS** · Class II · device recall initiated 2017-04-18.

## 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

- **Recall number:** Z-2591-2018
- **Recalling firm:** ELITech Clinical Systems SAS
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2591-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2591-2018. Source: US FDA. Licensed CC0.

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