ELITech Clinical Systems SAS: Medical Device Recall in 2018 - (Recall #: Z-2591-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 18, 2017

Date Posted: August 8, 2018

Recall Number: Z-2591-2018

Event ID: 80321

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated