BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1724-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1724-2015
    Event ID
    71174
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 6, 2015
    Classification Date
    June 8, 2015
    Termination Date
    May 25, 2018
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    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.

    Reason

    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.

    Code Info

    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.

    Distribution

    Worldwide distribution. US Nationwide, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.

    Quantity

    45 units worldwide (Domestic: 19 units, Foreign: 26)