BEUDAMED
    FDA Enforcement Class II Ongoing

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    Recall: Z-2285-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2285-2019
    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 GBS Assay , REF 50-10021, UDI # 00840487100165

    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 50-10021: AA7546 - 3/9/2019 AA7629 - 4/10/2019

    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