Events

Recall of Device Recall VITROS Chemistry Products Digoxin (DGXN) Slides

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
    62612
  • Event Risk Class
    Class 2
  • Event Number
    Z-2211-2012
  • Event Initiated Date
    2012-06-28
  • Event Date Posted
    2012-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111146
  • 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
    Enzyme immunoassay, digitoxin - Product Code LFM
  • Reason
    Ortho clinical diagnostics revised the vitros chemistry products dgxn slides instructions for use (ifu) and removed heparin plasma as a recommended specimen type for vitros dgxn slides.
  • Action
    Ortho Clinical Diagnostics sent an Urgent Field Safety Notice dated June 28, 2012, via US Postal Service Priority Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Immediately discontinue using heparin plasma samples and use only serum samples when processing VITROS DGXN Slides; Notify their laboratory and medical staff of this change and forward the information if the product have been distributed outside of your facility; Replace the pages of their VITROS Instructions for Use Manual with the enclosed Instructions for Use and Table of Contents; and Discontinue using any copies of the VITROS¿ DGXN Slide IFU (Version 7.0).--- On 28 June 2012 an Urgent Field Safety Notice was sent via US Postal Service Priority Mail to all affected Distributors. They were advised of the issue and instructed to discontinue distributing and discard their remaining inventory of VITROS DGXN Slides. --- Foreign affiliates were informed by email on 28 June 2012 of the issue and instructed to notify their consignees of the issue and actions. The letters included a Confirmation of Receipt form to be completed and return. For questions contact Customer Technical Servives at 1-800-421-3311

Device

Device Recall VITROS Chemistry Products Digoxin (DGXN) Slides
  • Model / Serial
    Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Product Description
    VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. || Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • 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