BEUDAMED
    FDA Recall Terminated

    SoftCytogenetics

    Recall: Z-2098-2021 · Initiated March 31, 2021

    Recall

    Recall Number
    Z-2098-2021
    Event Number
    88105
    Firm
    Soft Computer Consultants, Inc.
    FEI Number
    1000307651
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    March 31, 2021
    Terminated
    February 14, 2023
    Address
    5400 Tech Data Dr, Clearwater, FL, 33760-3116

    Description

    SoftCytogenetics

    Reason

    Software is given wrong results going out to HIS on test that had reruns.

    Action

    Dear SoftCytogentics Customer, The purpose of this letter is to advise you that SCC is voluntarily recalling SoftCytogenetics 4.1.11.20 and 4.1.12.11. There are software errors in these versions which SCC has designated to pose a potential risk-to-health issue. Reason for the Voluntary Recall: This task is to inform you of functionality in SoftCytogentics which SCC has designated to be a potential patient Risk-to-Health issue. For clients using Outbound Result Reporting with Resulting Profiles including Test Chapter macros, for cases that had multiple runs for reportable fields included to the Test Chapter macro, results from incorrect run may be sent outbound in HL7 message. Risk to Patient Care: When the results for test are processed with more than one run, and test uses the outbound reporting configuration of Resulting Profile* with Test Result macro added within, then some of results related to last reportable run can be sent outbound with values coming from any of the previous runs. These values are picked randomly from the previous runs. YOUR FACILITY DOES NOT CURRENTLY USE THIS CONFIGURATION. A hot fix would be required if you decide to implement this result reporting configuration prior to the next patch. Corrective Action: This issue will be corrected in the next software patch. Actions to be taken by the Customer/User: Please acknowledge receipt of this task and choose one of the following options: Workflow or functionality not used Agree to use alternative working solution Request hot fix if you decide to implement this result reporting configuration prior to the next patch.

    Distribution

    US Nationwide Distribution in the states of CA, FL, MN and NJ.

    Quantity

    5