BEUDAMED
    FDA Recall Terminated

    BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.

    Recall: Z-0981-2019 · Initiated January 14, 2019

    Recall

    Recall Number
    Z-0981-2019
    Event Number
    82046
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    PIC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 14, 2019
    Terminated
    April 3, 2020
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.

    Reason

    False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.

    Action

    BD Diagnostic Systems issued "URGENT MEDICAL DEVICE PRODUCT ADVISORY" Customer letters via UPS on January 14, 2019. The letters described the product, problem, and actions to take. The customers were instructed to do the following: 1. Complete the attached Customer Response Form and return to BD Regulatory Compliance at Email: [email protected] or Fax to: No.: 410-316-4258 whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Although prevalence rates are considered to be low, if no other cause of enteric infection is determined you may choose to confirm any negative result for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides obtained using the BD MAX Extended Enteric Bacterial Panel assay using an alternate method or using sample buffer tubes from a lot of EBP not listed above. Note that treatment for these infections is mainly supportive and antibiotics are not commonly used except in severe cases. 3. If your laboratory uses the xEBP assay and you would like replacement of your EBP kit(s), please complete the acknowledgement form included in the letter and return it via the instructions on the form. 4. Share this Advisory Letter with all users of the BD MAX instrument within your facility to ensure awareness. BD will provide replacement upon request using the Customer Response form. If you require further assistance, please contact: BD Customer/Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States.

    Distribution

    Worldwide Distribution: US (nationwide) to states of:CA, GA, HI, ID, MI, MN, MT, NJ, NM, OH, OR, PA, SC, TX, VA, VT, WA ; and to countries of: Australia, New Zealand, Canada, Europe, and Korea.

    Quantity

    1583 assay kits