BEUDAMED
    FDA Recall Terminated

    BD" Mouse IgG2a Isotype Control APC X39 ASR

    Recall: Z-2333-2021 · Initiated July 22, 2021

    Recall

    Recall Number
    Z-2333-2021
    Event Number
    88341
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 22, 2021
    Terminated
    March 24, 2023
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD" Mouse IgG2a Isotype Control APC X39 ASR

    Reason

    Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.

    Action

    On 07/22/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via FedEx to customers to inform them that the Recalling Firm received 3 complaints for performance issues related to high background and staining. Our investigation has confirmed there was an error during the manufacturing process that can potentially cause a false positive staining due to contamination with another antibody. Customers are instructed to: 1) Immediately review their inventory for the specific Catalog and lot number listed in the Recall Notification above. Destroy all product subject to the recall following their institution process for destruction. 2) Share this recall notification with all users of the product within their facility to ensure that they are also aware of this recall. If the affected product was used to generate test results, review potential impact to test results following their institution's policies. 3) Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated. Actions being taken by the Recalling Firm: 1) An investigation has been initiated to identify root cause and corrective actions to prevent recurrence. 2) The Recalling Firm will provide replacement for any discarded product. For questions or additional assistance contact North American Regional Complaint Center at 1-844-8BD-LIFE (1-844-823-5433) M-F 8am -5pm CT

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.

    Quantity

    23 reagents