Events

Recall of VITROS 3600

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
    60881
  • Event Risk Class
    Class 3
  • Event Number
    Z-1072-2012
  • Event Initiated Date
    2011-04-13
  • Event Date Posted
    2012-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106704
  • 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) received customer complaints regarding the loss of calibration data following the installation of a development assay data disk (add) that was available in the on-screen mailbox on the main menu system status screen of their vitros¿ 5600 integrated system. ocd's investigation determined that add, data release version (drv) 9241 or 9251 was electronically transferr.
  • Action
    Ortho-Clinical Diagnostics (OCD) sent an Important Product Correction Notification letters dated April 13, 2011 via FedEx overnight to customers with an affected VITROS¿ 3600 or 5600 System (those not e-Connected). Foreign affiliate consignees were informed of this action via e-mail on April 13, 2011. The letters described the affected products, problem and actions to be followed. The letters states that an OCD Field Engineer will contact customers who has the affected products and perform a Modification (MOD) procedure that will remove ADD DRV 9241 or 9251 from the on-screen mailbox of their system(s). Customers were instructed to complete and return the accompanying Confirmation of Receipt Form and fax to1-888-557-3759 or 1-585-453-4110. The letter asks that distributors forward a copy of the enclosed customer communication to all customers who were shipped an affected VITROS¿ 3600 or 5600 System. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.

Device

VITROS 3600
  • Model / Serial
    All VITROS¿ 3600 Systems Catalog # 6802783 that have not been eConnected which may have Assay Data Disk (ADD) Data Release Version (DRV) 9241 or 9251. J/Serial Numbers: 36000206, 36000268, 36000269, 36000290, 36000319, 36000404, 36000414, 36000416, 36000426,  36000430, 36000453, 36000464, 36000466, 36000467, 36000475, 36000143, 36000151, 36000152, 36000159, 36000165, 36000187, 36000194, 36000198, 36000204, 36000222, 36000228, 36000257, 36000258, 36000271, 36000275, 36000279, 36000301, 36000306, 36000307, 36000313, 36000315, 36000322, 36000324, 36000325, 36000326, 36000327, 36000330, 36000332, 36000333, 36000335, 36000336, 36000338, 36000342, 36000347, 36000348, 36000352, 36000353, 36000355, 36000360, 36000364, 36000365, 36000372, 36000374, 36000382, 36000384, 36000389, 36000390, 36000391, 36000392, 36000394, 36000395, 36000400, 36000401, 36000403, 36000405, 36000408, 36000421, 36000422, 36000425, 36000429, 36000431, 36000434, 36000438, 36000441, 36000442, 36000443, 36000448, 36000461, 36000462, 36000468, 36000469, 36000470, 36000471, 36000472, 36000473, 36000476, 36000477, 36000478, 36000479, 36000481, 36000483. -- NOTE: VITROS¿ 3600 that are e-Connected are not affected by this issue.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela.
  • Product Description
    VITROS¿ 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS¿ 3600 --- NOTE: VITROS¿ 3600 that are e-Connected are not affected by this issue. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS¿ Immunodiagnostic Products Reagents.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

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