BEUDAMED
    FDA Enforcement Class II Terminated

    Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic

    Recall: Z-1921-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1921-2016
    Event ID
    73658
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    March 24, 2016
    Classification Date
    June 7, 2016
    Termination Date
    February 13, 2017
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic

    Reason

    Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.

    Code Info

    Lot 1717357 Exp: 31Aug2017

    Distribution

    US distribution in MO.

    Quantity

    2 units were imported and distributed domestically