Events

Recall of VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.

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
    29887
  • Event Risk Class
    Class 3
  • Event Number
    Z-1473-04
  • Event Initiated Date
    2004-07-28
  • Event Date Posted
    2004-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34728
  • 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
    C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
  • Reason
    The immuno-rate (ir) wash detection algorithm may result in inappropriate wash detections.
  • Action
    Letters dated 7/28/2004. Distributors instructed to destroy product. Users instructed to use revised IR wash tolerance values (provided with letter). A Calibration Diskette, Data Release Version 5384 will also be provided to end users.

Device

VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per ...
  • Model / Serial
    Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    DOMESTIC distribution (nationwide): Product shipped to 6 distributors, 140 hospitals, and 6 U.S. government accounts. FOREIGN distribution: Product shipped to 22 Ortho-Clinical/J&J; affiliates in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain. The foreign affiliates further distributed product.
  • Product Description
    VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.
  • 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