BEUDAMED
    FDA Enforcement Class II Terminated

    Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.

    Recall: Z-0290-2018 · Reported January 3, 2018

    Enforcement

    Recall Number
    Z-0290-2018
    Event ID
    78728
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 3, 2018
    Initiation Date
    December 8, 2017
    Classification Date
    December 26, 2017
    Termination Date
    July 22, 2020
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.

    Reason

    The serum may fail to agglutinate within the specified minimum reaction time.

    Code Info

    UDI 50560805009592. Kit lot #1465529, Bottle lot #1465528; Kit lot #2118879, Bottle lot #1847290; Kit lot #2173683, Bottle lot #1847290; Kit lot #2161363, Bottle lot #1847290; Kit lot #1984639, Bottle lot #1847290; Kit lot #1738564, Bottle lot#1738565; Kit lot #1971308, Bottle lot #1738565; Kit lot #1957305, Bottle lot #1738565; Kit lot #1947930, Bottle lot #1738565; and Kit lot #1847285, Bottle lot #1738565.

    Distribution

    US Nationwide Distribution

    Quantity

    237 units (single bottles)