BEUDAMED
    FDA Enforcement Class II Terminated

    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    Recall: Z-2204-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2204-2017
    Event ID
    77209
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cell Marque Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    May 5, 2017
    Classification Date
    June 1, 2017
    Termination Date
    September 7, 2017
    Address
    6600 Sierra College Blvd, Rocklin, CA, 95677-4306, United States

    Description

    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

    Reason

    Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.

    Code Info

    0.5 ml lot 1418111A , expiry 2017-05; 1.0 ml lot, 1619706E , expiry 2019-06; 7.0 ml lot 1418112A, expiry 2017-05; lot 14181, expiry 12G 2017-05.

    Distribution

    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.

    Quantity

    10