FDA Medical Device Recalls (openFDA)
ELITech Clinical Systems SAS: 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
- Recalling firm
- ELITech Clinical Systems SAS
- 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
- Status
- Terminated
- Initiated
- 2017-04-18
- Posted
- not on file
- Terminated
- 2020-04-17
- 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.
- Root cause
- Under Investigation by firm
- Action
- ELITech Clinical Systems SAS notified consignees on April 18, 2018 via USPS certified letter, dated April 10, 2018 titled Product Recall Notice. The Product Recall Notice provided customers/consignees reason for recall, actions to be taken, and included a confirmation of receipt of product recall notice form to be filled out and returned by customer/consignee.
- Quantity
- not on file
- Distribution
- U.S. only. No gov. accounts. No international.
- Lot, serial or model codes
- Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019
- 510(k) numbers
- ["K945271"]
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 3007662974
- Firm city
- Sees
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28