BEUDAMED
    FDA Recall Terminated

    K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".

    Recall: Z-0923-2011 · Initiated September 17, 2008

    Recall

    Recall Number
    Z-0923-2011
    Event Number
    50074
    Firm
    Kamiya Biomedical Company, LLC
    FEI Number
    2084025
    Product Code
    MGA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 17, 2008
    Posted
    January 19, 2011
    Terminated
    January 20, 2011
    Address
    12779 Gateway Dr S, Tukwila, WA, 98168-3308

    Description

    K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".

    Reason

    Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.

    Action

    Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed. For questions regarding this recall call 1-800-222-0342.

    Distribution

    Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.

    Quantity

    5 kits