BEUDAMED
    FDA Recall Terminated

    Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

    Recall: Z-1002-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1002-2015
    Event Number
    70106
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    December 19, 2014
    Posted
    January 20, 2015
    Terminated
    March 11, 2016
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

    Reason

    Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.

    Action

    BD sent a Recall notification letters dated December, 2014 to affected customers via Certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for affected lots, immediately remove affected reagents from their laboratory, request replacement product and complete and return the enclosed Tracking/Verification form, per the instructions. For questions contact BD Customer Support at 855-236-2772.

    Distribution

    US Nationwide Distribution in the states of CA, NY, and MI

    Quantity

    15 units