Z-2591-2018Class II

ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL...

Name: Z-2591-2018 ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL...
Creator: ELITech Clinical Systems SAS
Published: 2017-04-18
License: https://open.fda.gov/license/

VitalScientific / initiated 2017-04-18 / Terminated / root cause: manufacturing process

FDA source

ELITech Clinical Systems SAS began a recall of 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 on 2017-04-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2591-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-18
Posted: 2018-08-01
Terminated: 2020-04-17
Recalling firm: VitalScientific
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
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: manufacturing process
FDA 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.
Distribution: U.S. only. No gov. accounts. No international.
Product codes and lots: Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2591-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2591-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-01

Product code JIX

K945271Class IAtac 8000 Random Access Chemistry SystemBio-Chem Laboratory Systems, Inc. / cleared 1995-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)