BEUDAMED
    FDA Recall 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 · Initiated March 18, 2019

    Recall

    Recall Number
    Z-1328-2019
    Event Number
    82665
    Firm
    Opgen Inc
    FEI Number
    3007065145
    Product Code
    LJG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 18, 2019
    Terminated
    August 5, 2019
    Address
    708 Quince Orchard Rd, Ste 220, Gaithersburg, MD, 20878-1764

    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

    Action

    OpGen issued recall letter via email on March 18, 2019. The notification provided reason for recall, health risk, and request to destroy any remaining inventory and return the completed Acknowledgement of Receipt of Notification Letter via OpGen, Inc., Attn: Autumn Collasius Regulatory Affairs,708 Quince Orchard Dr., Suite 205, Gaithersburg, MD 20878; Phone: 1 (301) 869-9683 Fax: 1 (301) 869-9684, e-mail: [email protected]. The response form asks the customer to include how many of the affected slides they currently have in stock and how many they have already used. Questions or requests for further information, please contact OpGen Technical Support: US (Toll-Free): 1-866-376-0009 FAX: 1-301-869-9684 E-mail: [email protected]

    Distribution

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

    Quantity

    80 slides