BEUDAMED
    FDA Enforcement Class II Terminated

    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    Recall: Z-0611-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0611-2019
    Event ID
    81678
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2018
    Initiation Date
    November 14, 2018
    Classification Date
    December 14, 2018
    Termination Date
    June 8, 2020
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607, United States

    Description

    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    Reason

    There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

    Code Info

    Lot #s 251504, 251916, 252243, 252364, 252887, 253211

    Distribution

    US Nationwide Distribution

    Quantity

    22342 total