Events

Recall of VITROS VANC (vancoymycin) Reagent

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

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
    33896
  • Event Risk Class
    Class 2
  • Event Number
    Z-0173-06
  • Event Initiated Date
    2005-10-12
  • Event Date Posted
    2005-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42702
  • 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
    Radioimmunoassay, Vancomycin - Product Code LEH
  • Reason
    Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
  • Action
    Letters dated 10/12/2005 issued to end users in the U.S. Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol. A return reply form is included. Foreign affiliates were notified via e-mail on 10/12/2005.

Device

VITROS VANC (vancoymycin) Reagent
  • Model / Serial
    01-5919, Exp. 5/31/2005 (EXPIRED):  01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J; affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela.
  • Product Description
    VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA