BEUDAMED
    FDA Enforcement Class II Terminated

    Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

    Recall: Z-0982-2019 · Reported March 13, 2019

    Enforcement

    Recall Number
    Z-0982-2019
    Event ID
    82077
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 13, 2019
    Initiation Date
    January 31, 2019
    Classification Date
    March 7, 2019
    Termination Date
    June 9, 2020
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

    Reason

    Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

    Code Info

    Catalog Number 8199; Lot Number (original expiration date YYYY/MM/DD, new expiration date YYYY/MM/DD): 8199-02 (2019/02/28, 2018/03/31), 8199-03 (2019/02/28, 2018/03/31), 8199-04 (2019/05/31, 2018/06/30), 8199-05 (2019/05/31, 2018/06/30), 8199-06 (2019/10/31, 2018/11/30), 8199-07 (2019/05/31, 2018/06/30), 8199-08 (2019/12/31, 2019/01/31), 8199-09 (2019/05/31, 2018/06/30), 8199-10 (2020/01/31, 2019/02/28), 8199-11 (2020/01/31, 2019/02/28), 8199-12 (2020/01/31, 2019/02/28), 8199-13 (2020/01/31, 2019/02/28), 8199-17 (2020/04/30, 2019/05/31), 8199-18 (2020/05/31, 2019/06/30), 8199-19 (2020/10/31, 2019/11/30)

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden, Switzerland, United Kingdom.

    Quantity

    704 units