BEUDAMED
    FDA Enforcement Class II Ongoing

    binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101

    Recall: Z-1626-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1626-2023
    Event ID
    92143
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Binx Health, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 31, 2023
    Initiation Date
    March 29, 2023
    Classification Date
    May 23, 2023
    Address
    245 1st St Ste 18, Riverview II, Cambridge, MA, 02142-1292, United States

    Description

    binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101

    Reason

    May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results

    Code Info

    UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023

    Distribution

    In the US state of PA

    Quantity

    50 single-use cartridges