Events

Rappel de Device Recall enGen Laboratory Automation 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
    71174
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1724-2015
  • Date de mise en oeuvre de l'événement
    2015-05-06
  • Date de publication de l'événement
    2015-06-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136349
  • 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
    Recapper caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. the gripper may grab a tube at the wrong height and drop the tube in the rack entry/exit or rack exit module. these situations may result in splashing of bio-hazardous fluid. sample cross-contamination may occur with an uncapped tube in the rack.
  • Action
    On 5/06/2015, a customer letter (Ref. CL2015-092) with recommendation to prevent this issue was sent to all customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by email to subscribers of ORTHO PLUS e-Communications. Foreign affiliate consignees were notified by e-mail on 5/06/2015 informing them of the issue. For questions, please call Customer Technical Services at 1-800-421-3311 at any time.

Device

Device Recall enGen Laboratory Automation System
  • Modèle / numéro de série
    Serial Numbers: J89134, JIM341226, 341516, JIM342964, JIM340432, JIM340814, IM341243, JIM336912, J271265, J271369, J271372, J271267, J85208, JIM342217, J7023890, J7023841, J7025007, J7024894, J7023648,  J7021530, J57662, J8006290, J75685, J30370, J3055510, J3055507, JIM341820, JIM341679, JIM341174, JIM340667, JIM-341592, JIM336957,  JIM341477, JIM336855, JIM334236, JIM341415, JIM341392, JIM340934,  JIM336167, JIM342249, JIM341750, JIM341426, JIM334527, JIM341021, JIM340658.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US Nationwide, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.
  • Description du dispositif
    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). || COMMON NAME: enGen Track System. The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.
  • 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