BEUDAMED
    FDA Recall Terminated

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    Recall: Z-0188-2020 · Initiated September 26, 2019

    Recall

    Recall Number
    Z-0188-2020
    Event Number
    83786
    Firm
    Life Technologies Holdings Pte Ltd Blk
    FEI Number
    3003673482
    Product Code
    PFF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 26, 2019
    Terminated
    November 23, 2021
    Address
    33 Marsiling Ind Estate Road, 3 # 07-06, Singapore, Singapore

    Description

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    Reason

    Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant

    Action

    1. Notify all PGM Dx users in your facility of this issue. 2. Require that the Test_Report.pdf file be used for reporting results for all future sample tests. 3. Require that the Test_Report.pdf file be used to confirm ALL positive call results. For sample result reporting that use the Test_Report.pdf file and NOT the Target_Summary.tab file, the results are valid, and no further action is needed. For sample result reporting that use the Target_Summary.tab file on the Torrent SuiteTM Dx software versions indicated above, customers MUST review ALL results obtained using the Target_Summary.tab file against the results shown in the Test_Report.pdf file to identify any occurrences of possible false positive reporting. 4. If you have shared reports using results from the Target_Summary.tab file, outside of your facility, you MUST notify those customers or facilities to take the required action. 5. Please complete the following Customer Response Sheet and submit sheet, along with this letter, by emailing a scanned copy to [email protected]. If you have any technical questions or concerns, please contact Technical Support at 800-955-6288 option 4 or [email protected]

    Distribution

    states : AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA OUS: South Korea, ITALY, China, Japan, Singapore, Germany, TAIWAN, Poland

    Quantity

    total of Ion+vela +chassis =400 units