Events

Rappel de Device Recall VITROS 4600 Chemistry System

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
    64577
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1107-2013
  • Date de mise en oeuvre de l'événement
    2013-02-07
  • Date de publication de l'événement
    2013-04-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116521
  • 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, inc. (ocd) determined that extension springs on some vitros¿ systems may be out of its manufacturing specifications. extension springs are part of the slide alignment guide assembly. during an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. if the extension spring does not provide sufficient force, microslides may not be properly positioned within the microslide incubator which has the potential to cause imprecise results. extension springs are just one component in the slide alignment assembly. ocd's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
  • Action
    URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS¿ System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.

Device

Device Recall VITROS 4600 Chemistry System
  • Modèle / numéro de série
    Serial Numbers 46000108 through 46000217
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
  • Description du dispositif
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. || Intended for use in the measurement of a variety of chemistry analytes.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA