Events

Rappel de VITROS 3600

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ortho-Clinical Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60881
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1072-2012
  • Date de mise en oeuvre de l'événement
    2011-04-13
  • Date de publication de l'événement
    2012-02-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106704
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA