BEUDAMED
    FDA Recall Terminated

    Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.

    Recall: Z-0822-2019 · Initiated December 26, 2018

    Recall

    Recall Number
    Z-0822-2019
    Event Number
    81890
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    PAM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 26, 2018
    Posted
    February 11, 2019
    Terminated
    August 4, 2020
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    Description

    Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.

    Reason

    On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

    Action

    The firm, Luminex, notified the consignees by email with a letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 12/20/2018 on 12/26/2018. The letter described the product, problem and actions to be taken. The customers were instructed to: Please check your VERIGENE BC-GP Utility Kit inventory to determine if you have any of the listed products; if product(s) is (are) located within your inventory, please follow the instructions and information about destroying any found recalled product at your facility, and complete and return Acknowledgment and Receipt form an email, and send it on or before January 15, 2019 to [email protected] or by mail to: Luminex Corporation Attn: Global Support Services 12201 Technology Boulevard Suite 130 Austin, TX 78727 The firm expanded the recall to include one new lot and notified the consignees on 01/17/2019. This lot was to be destroyed. Please call the Luminex-Global Support Services with any questions or concerns at 1-877-785-2323 (U.S. and Canada) (24 hours/7days); +1-512-381-4397 (Outside U.S. and Canada) (24 hours/7days) or email [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.

    Quantity

    1132 carriers