BEUDAMED
    FDA Enforcement Class II Terminated

    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

    Recall: Z-0422-2022 · Reported January 5, 2022

    Enforcement

    Recall Number
    Z-0422-2022
    Event ID
    89041
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 5, 2022
    Initiation Date
    November 9, 2021
    Classification Date
    December 27, 2021
    Termination Date
    February 10, 2025
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320, United States

    Description

    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

    Reason

    There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.

    Code Info

    Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI. There was government distribution but no military distribution.

    Quantity

    1,043 units