BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0982-2019 · Initiated January 31, 2019

    Recall

    Recall Number
    Z-0982-2019
    Event Number
    82077
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    PMN
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 31, 2019
    Posted
    March 7, 2019
    Terminated
    June 9, 2020
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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.

    Action

    On about 01/31/2019, Microbiologics notified customers via an "Important Medical Device Correction" letter, sent through email. The letter notified customers of the change in expiration date, instructed customers to update their records with the provided new expiration date, to not use the product after the expiration date, and to complete and return the "MEDICAL DEVICE CORRECTION CUSTOMER RESPONSE FORM." For questions, contact Technical Support at 1-320-229-7064 or [email protected].

    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