Events

Recall of Device Recall VITROS Chemistry Products Calibrator Kit 16

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
    60679
  • Event Risk Class
    Class 2
  • Event Number
    Z-0714-2012
  • Event Initiated Date
    2011-11-10
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106192
  • 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
    System, test, rheumatoid factor - Product Code DHR
  • Reason
    Ortho clinical diagnostics is recalling lot 1630 of vitros¿ calibrator kit 16 because it will not likely meet its specified 12 months of stability.
  • Action
    A letter was sent to customers via overnight delivery on 11/10/2011. The letter informed customers they should discontinue using and discard all remaining VITROS Calibrator Kit 16, Lot 1630; Complete and return the attached Confirmation of Receipt form upon receipt of the notification. Once the fax reply is received, the firm will begin the replacement order process; forward the notification to all departments and areas that use the VITROS Calibrator Kit 16, Lot 1630; and post the notification by each VITROS Chemistry or Integrated System in your facility that uses the VITROS Calibrator Kit 16, Lot 1630 or with VITROS user documentation.

Device

Device Recall VITROS Chemistry Products Calibrator Kit 16
  • Model / Serial
    Lot 1630
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall: Worldwide Distribution - USA (Nationwide) and the countries of Brazil, Canada, Chile, China, Colombia, England, France, Mexico, Panama, Singapore, Spain, Venezuela.
  • Product Description
    VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA