BEUDAMED
    FDA Enforcement Class II 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 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0188-2020
    Event ID
    83786
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies Holdings Pte Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    September 26, 2019
    Classification Date
    October 23, 2019
    Termination Date
    November 23, 2021
    Address
    Blk 33 Marsiling Ind Estate Road 3, #07-06, Singapore, N/A, 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

    Code Info

    The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type

    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