Events

Recall of Device Recall Vitros

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
    26148
  • Event Risk Class
    Class 3
  • Event Number
    Z-0919-03
  • Event Initiated Date
    2003-03-26
  • Event Date Posted
    2003-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27175
  • 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
    Biuret (Colorimetric), Total Protein - Product Code CEK
  • Reason
    Slides may exhibit random, elevated imprecision of results.
  • Action
    Notification via letter dated 3/26/03 with instructions to discard product.

Device

Device Recall Vitros
  • Model / Serial
    All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide.
  • Product Description
    Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14650-0881
  • Source
    USFDA