BEUDAMED
    FDA Recall Terminated

    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) 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. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.

    Recall: Z-1677-2014 · Initiated March 20, 2014

    Recall

    Recall Number
    Z-1677-2014
    Event Number
    68263
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 20, 2014
    Posted
    June 2, 2014
    Terminated
    April 11, 2017
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) 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. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.

    Reason

    Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.

    Action

    US consignees were sent Urgent Product Correction Letters (Cl2014-102, dated 3/20/2014) on 3/20/2014 by FedEx or USPS (for PO Box addresses only) overnight mail, informing them of the issue and instructing them to ensure that all required data elements are entered and in the correct format when using the auto verification feature or custom rules. J&J Foreign affiliate consignees were notified by e-mail on 3/20/2014 informing them of the issue.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

    Quantity

    Domestic: 20 units, Foreign: 61 units