BEUDAMED
    FDA Recall Terminated

    Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513

    Recall: Z-2106-2021 · Initiated May 27, 2021

    Recall

    Recall Number
    Z-2106-2021
    Event Number
    88072
    Firm
    Cell Marque Corporation
    FEI Number
    3000718726
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 27, 2021
    Terminated
    April 5, 2024
    Address
    6600 Sierra College Blvd, Rocklin, CA, 95677-4306

    Description

    Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513

    Reason

    Product distributed for use as an In-vitro Diagnostics without FDA clearance

    Action

    On May 27, 2021, Cell Marque Corporation issued a "Recall Notification" via e-mail to all affected consignee. On June 15, 2021 the firm issued a "Urgent Medical Device Recall Notification" to provide additional information. This communication was sent via e-mail. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. 2.Cell Marque is requesting that you destroy any unused or partially used containers of the products and that you provide us with confirmation that the product has been destroyed. If you have already used all the products, please confirm that the product has been used and is no longer available. Please complete the Attachment 1 confirmation of receipt form and return to local contact indicated below. 3. In addition, if you may have further distributed the product, please identify your customers and notify them of this issue immediately. Your notification to customers should include a copy of this notification. 4. Technical Services: Toll free at 800.665.7284 | Press 1. Additionally, email us at [email protected] 5. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A

    Quantity

    2 units