BEUDAMED
    FDA Enforcement Class II Ongoing

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    Recall: Z-2288-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2288-2019
    Event ID
    83470
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    February 20, 2019
    Classification Date
    August 15, 2019
    Address
    12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States

    Description

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    Reason

    Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.

    Code Info

    Lot numbers & discontinue use by dates for Part Number 50-10026: AA7126 Immediately AA7307 - Immediately AA7385 - Immediately AA7525 - 3/1/2019 AA7547 - 3/16/2019 AA7628 - 4/12/2019 AA7666 - 3/28/2019

    Distribution

    US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom

    Quantity

    N/A