BEUDAMED
    FDA Recall Terminated

    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

    Recall: Z-0895-2018 · Initiated August 2, 2017

    Recall

    Recall Number
    Z-0895-2018
    Event Number
    79165
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 2, 2017
    Posted
    March 3, 2018
    Terminated
    March 29, 2019
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443

    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.

    Action

    On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    14,894 kits