BEUDAMED
    FDA Recall 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 · Initiated May 6, 2015

    Recall

    Recall Number
    Z-1724-2015
    Event Number
    71174
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 6, 2015
    Posted
    June 8, 2015
    Terminated
    May 25, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    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.

    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.

    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)