Events

Recall of Device Recall Envoy 500 Serum Control Kit

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
    54279
  • Event Risk Class
    Class 2
  • Event Number
    Z-1233-2010
  • Event Initiated Date
    2009-12-04
  • Event Date Posted
    2010-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88126
  • 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
    Multi-Analyte Controls, All Kinds (Assayed) - Product Code JJY
  • Reason
    Vital diagnostics observed a bias in the quality control consensus program between published values for alp on the atac 8000 and reported customer means. the ranges were adjusted to reflect the analyzer population.
  • Action
    Customers were mailed copies of Technical Bulletin 8100 and 5024 dated September 30, 2009 which advised of the Alkaline Phosphatase QC value revisions for the Envoy 500 and the ATAC 8000. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822.

Device

Device Recall Envoy 500 Serum Control Kit
  • Model / Serial
    Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Envoy 500 Serum Control Kit. || The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
  • 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