BEUDAMED
    FDA Recall Terminated

    DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy

    Recall: Z-0776-05 · Initiated April 8, 2005

    Recall

    Recall Number
    Z-0776-05
    Event Number
    31735
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    LOL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 8, 2005
    Posted
    April 27, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy

    Reason

    The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).

    Action

    Customers notified via mail, fax or email beginning 04/08/05 with a DiaSorin Customer Notification Letter which also contained a copy of the correct package insert. Distributors were directed to forward copies of the recall letter and correct package insert to their customers. Customers are instructed to destroy the incorrect insert.

    Distribution

    Nationwide including: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV and Puerto Rico

    Quantity

    2104