Z-0217-2016Class II

Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450...

Name: Z-0217-2016 Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450...
Creator: ELITech Clinical Systems SAS
Published: 2015-09-22
License: https://open.fda.gov/license/

VitalScientific / initiated 2015-09-22 / Terminated

FDA source

ELITech Clinical Systems SAS began a recall of Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500... on 2015-09-22. FDA classified it as Class II and gives the reason as "ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0217-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Posted: 2015-11-05
Terminated: 2016-03-04
Recalling firm: VitalScientific
Product: Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.
FDA root cause: Under Investigation by firm
Action: The firm sent recall letters or Technical Bulletins to US consignees on 9/22/15 via registered mail. Technical Bulletin #1022 (for EON 100 users) Technical Bulletin #2008 (for EON 300 users) Technical Bulletin #5064 (for ENVOY users) Technical Bulletin #3009 (for Selectra users) ELITechGroup is not requesting return of the affected product. The method sheets and package inserts will be updated with the new interference claims. When available, the revised labeling will be provided to the customer for customer's use until the new IFU is included in the product packaging. Consignees are requested to return the Confirmation of Receipt form back to the firm by FAX to 401-642-9001 or send email to [email protected] or send via US Post: Vital Diagnostics, 27 Wellington Rd., Lincoln, Rl. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822 or 855-ELITECH
Quantity in commerce: 13455 systems
Distribution: US Nationwide Distribution
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0217-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0214-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04
Z-0215-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04
Z-0216-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04
Z-0217-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-04

Product code CGA

K100525Class IIElitech Clinical Systems Glucose Pap Sl Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol 1 and 2Seppim S.A.S. / cleared 2010-12-15

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)