BEUDAMED
    FDA Recall Open, Classified

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    Recall: Z-2283-2019 · Initiated February 20, 2019

    Recall

    Recall Number
    Z-2283-2019
    Event Number
    83470
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    PGI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 20, 2019
    Posted
    August 15, 2019
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    Description

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    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.

    Action

    On February 20, 2019, the firm sent a "Urgent: Medical Device Recall/Field Safety Notice" via email to all consignees. The customer notification informed customers of the following: 1. As an immediate action, Luminex is requesting that customers discontinue use of and discard the products listedin the recall notice immediately or by the Discontinue Use By date. Contact Luminex Global Support Services to obtain replacement material. Material that is still within its Discontinue Use By date may be used at the customers discretion. 2. Complete the Acknowledgment and Receipt form. You must complete and return this form even if you do not have any remaining product. Luminex Technical Support can assist you in completing this form. This information is essential in order to maintain recall effectiveness information required by US FDA. 3. Although no adverse events have been reported, adverse reaction or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 4. Please call the Luminex Global Support Services Team if you have any questions or concerns. Luminex Global Support Services 1-877-785-2323 (U.S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) [email protected] CAN-0233

    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