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
    68271
  • Event Risk Class
    Class 2
  • Event Number
    Z-1735-2014
  • Event Initiated Date
    2014-04-10
  • Event Date Posted
    2014-06-09
  • 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=127246
  • 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
    clinical chemistry analyzer - Product Code JJE
  • Reason
    Potential for biased results when a multiple window (mw) code is associated with results generated by the vitros 4600 chemistry system, the vitros 5600 integrated system and the vitros 5,1 chemistry system. mw codes may be associated with results from any of the following vitros chemistry products using multiple point (multipoint) rate measurements. the microslide assays that could be affected.
  • Action
    Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without an MW code are acceptable. -- Review their current Laboratory Information System (LIS) configuration to determine if changes are required in order to restrict reporting of results with an MW code. Customers with questions should contact Customer Technical Services at 1-800-421-3311. --- Foreign affiliates were informed of the issue by e-mail on 4/10/2014 and instructed to notify their consignees of the issue and actions.

Device

VITROS 5600 Integrated System
  • Model / Serial
    Software Version 3.0 and lower; Serial Numbers J56000110 through J56001912
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Product Description
    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
  • 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