BEUDAMED
    FDA Enforcement Class II Ongoing

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    Recall: Z-2284-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2284-2019
    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 Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    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 and discontinue use by dates for Part Number 50-10020: AA7127 - Immediately; AA7206 - Immediately; AA7312 - 3/5/2019; AA7549 - 3/30/2019; AA7635 - 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