BEUDAMED
    FDA Recall Terminated

    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

    Recall: Z-2093-2021 · Initiated March 31, 2021

    Recall

    Recall Number
    Z-2093-2021
    Event Number
    88095
    Firm
    Soft Computer Consultants, Inc.
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    March 31, 2021
    Terminated
    April 15, 2022
    Address
    5400 Tech Data Dr, Clearwater, FL, 33760-3116

    Description

    SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

    Reason

    Software showing wrong results reported, PDF not match HIS.

    Action

    The firm sent an " URGENT: MEDICAL DEVICE RECALL" letter dated 6/2/2021 to its sole consignee of the correction on 06/02/2021 by mail. The letter described the product, problem and actions to be taken. The consignee was instructed to do the following: Acknowledge receipt of this letter in the TMS task Give permission to load Hot Fix on Test environment Perform validation activities to completion Acknowledge Hot Fix has been moved to Live environment and is working as expected Type of action by Company: All clients on affected lines of software have been notified of the recall. SCC will provide Hot Fixes for all affected lines that will be delivered to all affected clients. Until the software correction is delivered, clients have been informed of an alternative workflow to avoid the problem. The firm provided information on a software update performed on 03/31/2021 and stated that, "Hot Fix has already been delivered." If you have any further questions, Please call 1-800-763-8522 (Technical Support 24/7).

    Distribution

    US Distribution to: CA only

    Quantity

    1