BEUDAMED
    FDA Recall Terminated

    K-Assay Lp(a) Control

    Recall: Z-0940-04 · Initiated March 29, 2004

    Recall

    Recall Number
    Z-0940-04
    Event Number
    28825
    Firm
    Kamiya Biomedical Company
    FEI Number
    2084025
    Product Code
    DFC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2004
    Posted
    July 20, 2004
    Terminated
    July 9, 2004
    Address
    910 Industry Dr, Seattle, WA, 98188-3412

    Description

    K-Assay Lp(a) Control

    Reason

    Assay result not consistent with the assigned control value

    Action

    On 3/30/04 customers were faxed a letter and mailed a letter. The letter advises of the problem, requests the customer to discontinue using product, and requests return of the product.

    Distribution

    The firm distributed product to 3 distributors, 1 each in CA, PA, and MN; and 2 labs, 1 each in GA and MI.

    Quantity

    16