Events

Recall of Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66202
  • Event Risk Class
    Class 2
  • Event Number
    Z-0732-2014
  • Event Initiated Date
    2013-08-29
  • Event Date Posted
    2014-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121742
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Azo dye, calcium - Product Code CJY
  • Reason
    High positive calcium bias on plasma sample versus results on serum.
  • 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.

Device

Device Recall Vital Diagnostics Envoy Calcium Reagent For InVitro Diagnostic Use
  • Model / Serial
    All lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. || PN 55285 || For the quantitative measurement of calcium in plasma and serum
  • Manufacturer
    Vital Diagnostics, Inc.

Manufacturer

Vital Diagnostics, Inc.
  • Manufacturer Address
    Vital Diagnostics, Inc., 27 Wellington Rd, Lincoln RI 02865-4411
  • Manufacturer Parent Company (2017)
    Ergon Capital Partners
  • Source
    USFDA