Events

Recall of Device Recall VITROS Chemistry Products UPRO 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
    75936
  • Event Risk Class
    Class 2
  • Event Number
    Z-1179-2017
  • Event Initiated Date
    2016-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151775
  • 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
    Lowry (colorimetric), total protein - Product Code JGP
  • Reason
    There is a potential for variable negatively and positively biased urine protein results using vitros upro slides.
  • Action
    On December 8, 2016, Ortho Clinical Diagnostics distributed Product Correction Notification letters to their customers via FedEx, ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to check their stock for affected product and to immediately discontinue and discard all remaining inventory. Ortho will credit your account for any discarded VITROS UPRO Slides, VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Please complete the Confirmation of Receipt and return by December 22, 2016. Customers with questions, please contact Ortho CareTM Technical Solutions Center at 1-800-421-3311.

Device

Device Recall VITROS Chemistry Products UPRO Slides
  • Model / Serial
    Product Code REF 680 0120 Lot: GENs 14-18  Expiry Date range 01-JAN-2017 through 01-MAY-2018
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
  • Product Description
    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, || Product Usage: || Quantitative measurement of total protein concentration in urine.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 513 Technology Blvd, Rochester NY 14626-3601
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA