BEUDAMED
    FDA Enforcement Class II Terminated

    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures

    Recall: Z-1328-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1328-2019
    Event ID
    82665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Opgen Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 22, 2019
    Initiation Date
    March 18, 2019
    Classification Date
    May 14, 2019
    Termination Date
    August 5, 2019
    Address
    708 Quince Orchard Rd Ste 220, Gaithersburg, MD, 20878-1764, United States

    Description

    CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification of E. coli, K. pneumoniae and P. aeruginosa directly from Gram-negative blood cultures

    Reason

    May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test

    Code Info

    Lot Number FN80107

    Distribution

    US Distribution to states of: CT, MI and VA.

    Quantity

    80 slides