Events

Recall of VITROS 5600 Integrated 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
    61790
  • Event Risk Class
    Class 2
  • Event Number
    Z-1699-2012
  • Event Initiated Date
    2012-04-26
  • Event Date Posted
    2012-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109085
  • 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 is recalling vitros 5600 integrated system software version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a curvetip position.
  • Action
    Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated April 26, 2012, via FedEx overnight courier to US consignees with VITROS¿ 5600 Systems. The letter identified the affected product, problem and actions to be taken. Foreign affiliates were informed by email on April 26, 2012 of the issue and instructed to notify their consignees of the issue and actions. OCD recommend customers to group all DAT assays into a single run as described in the letter, until the next Software Version 2.0 is installed on their VITROS¿ 5600 System. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311

Device

VITROS 5600 Integrated System
  • Model / Serial
    Product code: 6802413; Serial numbers: 56000118 - 56001498
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Product Description
    VITROS 5600 Integrated System Software Version 1.6 & Below || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA