BEUDAMED
    FDA Recall Terminated

    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent

    Recall: Z-2203-2017 · Initiated May 5, 2017

    Recall

    Recall Number
    Z-2203-2017
    Event Number
    77209
    Firm
    Cell Marque Corporation
    FEI Number
    3000718726
    Product Code
    NYQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 5, 2017
    Posted
    June 1, 2017
    Terminated
    September 7, 2017
    Address
    6600 Sierra College Blvd, Rocklin, CA, 95677-4306

    Description

    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - 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.

    Action

    Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email [email protected]. For questions regarding this recall call 916-746-8977.

    Distribution

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