Z-0733-2014Class II

Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement...

Name: Z-0733-2014 Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement...
Creator: Vital Diagnostics, Inc.
Published: 2013-08-29
License: https://open.fda.gov/license/

ELITechGroup Inc / initiated 2013-08-29 / Terminated / root cause: design

FDA source

Vital Diagnostics, Inc. began a recall of Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum on 2013-08-29. FDA classified it as Class II and gives the reason as "High positive calcium bias on plasma sample versus results on serum". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0733-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Posted: 2014-01-14
Terminated: 2015-08-26
Recalling firm: ELITechGroup Inc
Product: Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
Product code: CJY Azo Dye, Calcium
Reason for recall: High positive calcium bias on plasma sample versus results on serum
Root cause tag: design
FDA root cause: Device Design
Action: Vital Diagnostics issued a Recall Notice dated August 29, 2013, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use plasma for the determination of total calcium when using the affected product. The use of serum is acceptable, thus the product can still be used to determine total calcium with this sample type. Vital Diagnostics released a corection to the package insert for the Envoy Calcium Reagent. Customers with the affected product in their laboratory, were instructed to discard the insert packed with the product and replace it with the insert enclosed with this bulletin. If product was transferred to another location, the bulletin should be forwarded to that location. The package insert was revised indicating to only use Serum samples when running Calcium. Vital Diagnostics issued a revised (expanded) notice dated September 19, 2013, to include the Consult Diagnostics Eon Calcium Reagent (PN: 1429) requesting users to discontinue using the single vial Eon Calcium kit (PN: 1429). Customers with questions were instructed to call Vital Diagnostics Technical Support at 1-855-354-8324.. For questions regarding this recall call 401-642-8400.
Quantity in commerce: 213 units
Distribution: Nationwide Distribution
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0733-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0732-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0733-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14

Product code CJY

K120626Class IIEon Calcium RegentVital Diagnostics (Manufacturing) Ptyltd / cleared 2012-08-22

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)