BEUDAMED
    FDA Recall Terminated

    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.

    Recall: Z-1051-2017 · Initiated December 12, 2016

    Recall

    Recall Number
    Z-1051-2017
    Event Number
    76076
    Firm
    Great Basin Scientific, Inc.
    FEI Number
    3009071564
    Product Code
    PAM
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 12, 2016
    Posted
    January 19, 2017
    Terminated
    March 31, 2017
    Address
    2441 S 3850 W, Salt Lake City, UT, 84120-7209

    Description

    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.

    Reason

    The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.

    Action

    The firm, Great Basin Scientific, notified customers by phone beginning on December 12, 2016 and by email on December 14 and 15, 2016. The notifications described the product, problem and actions to be taken. The customers were instructed to cease using and immediately discard all affected cartridges, the firm will replace those cartridges as soon as possible; and respond to the email or call Direct: 385.219.4540 or Support Team 888.333.9763 or email: [email protected] with any questions or concerns.

    Distribution

    US Nationwide Distribution.

    Quantity

    32 Kits (320 individual disposable cartridges)