BEUDAMED
    FDA Recall Terminated

    Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.

    Recall: Z-1441-06 · Initiated July 18, 2006

    Recall

    Recall Number
    Z-1441-06
    Event Number
    35946
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GFO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2006
    Posted
    August 26, 2006
    Terminated
    November 6, 2006
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.

    Reason

    Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

    Action

    Recall notification letters were sent out via first class mail on July 18, 2006.

    Distribution

    Nationwide

    Quantity

    4,365 kits