Events

Recall of VITROS 4600 Chemistry System

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
    69234
  • Event Risk Class
    Class 2
  • Event Number
    Z-0077-2015
  • Event Initiated Date
    2014-09-08
  • Event Date Posted
    2014-10-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129992
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Ortho clinical diagnostics (ocd) identified an anomaly with software version 3.0 and below on the vitros 4600 chemistry systems and vitros integrated systems. internal testing confirmed that when using calibrator barcode labels supplied with vitros chemistry products calibrator kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.E., hidden).
  • Action
    On 9/08/14, URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-232, dated 9/8/14) and Confirmation of Receipt Form were sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government only) to inform them of the issue and advise them of the required actions. Foreign affiliates were informed of the issue via e-mail on 9/8/14 and instructed to notify their consignees of the issue and the required actions.

Device

VITROS 4600 Chemistry System
  • Model / Serial
    Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Product Description
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. || The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
  • 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