Events

Recall of Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes

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
    55535
  • Event Risk Class
    Class 3
  • Event Number
    Z-1816-2010
  • Event Initiated Date
    2010-04-12
  • Event Date Posted
    2010-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91076
  • 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
    Tube, sedimentation rate - Product Code GHC
  • Reason
    The tube may fall out or separate from the slider adapter.
  • Action
    Vital Diagnostics issued recall letter dated April 14, 2010 via Certified Mail in an envelop marked "Urgent Recall Information Inside", requesting accounts to discontinue use and destroy recalled product. A Certificate of Destruction and Refund Form was included to direct customers. A second Distributor Notice was sent by email to the distributors with Important Recall Information in the title. This was accompanied with the same Technical Bulletin, Certificate of Destruction and Refund Form. For further information, contact Vital Diagnostics at 1-800-345-2822.

Device

Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR Tubes
  • Model / Serial
    All Lot Numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and Canada.
  • Product Description
    Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. || Slider allows a larger label to be applied to the ESR tube.
  • 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