BEUDAMED
    FDA Recall Open, Classified

    Parvovirus B19 IgG EIA kit Part No. V519IGUS

    Recall: Z-2936-2020 · Initiated July 17, 2020

    Recall

    Recall Number
    Z-2936-2020
    Event Number
    86152
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MYL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 17, 2020
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Parvovirus B19 IgG EIA kit Part No. V519IGUS

    Reason

    Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value

    Action

    DiaSorin issued a customer notification letter on July 17, 2020. The letter states the following action to be taken: Please use the Lot Specific Constant value of 0.14 with your remaining inventory of Lot 71440040AA.. The Lot Specific Constant is used to calculate the cut-off value and use of the incorrect value may lead to: 1. An invalid test due to the Low Positive Control resulting above the upper limit of the assigned range. 2. The reporting of a false positive patient result if the Low Positive Control does not fail and invalidate the test run. If you have used the affected product Lot 71440040AA in combination with the incorrect Lot Specific Constant of 0.10 and you obtained valid runs, please: 1. Review the test results of these valid runs for values between 1.1 Index and 1.54 Index, which may have been falsely reported as positive. 2. Take actions as appropriate. 3. DiaSorin recommends discussing the content of this letter with your laboratory director with respect to the need to review previous test results, conduct patient follow-up and/or repeat testing as appropriate. Complete page two of this letter and return to DiaSorin Inc. Forward this letter to anyone in your organization who may be impacted. We apologize for any inconvenience this may cause. If you have any questions regarding this notice please contact DiaSorin Inc. Technical Support at 1-800-328-1482.

    Distribution

    NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada

    Quantity

    615 units