BEUDAMED
    FDA Enforcement Class II Terminated

    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

    Recall: Z-0895-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0895-2018
    Event ID
    79165
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Laboratory Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    August 2, 2017
    Classification Date
    March 3, 2018
    Termination Date
    March 29, 2019
    Address
    180 Hartwell Rd, N/A, Bedford, MA, 01730-2443, United States

    Description

    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

    Reason

    Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

    Code Info

    Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    14,894 kits