BEUDAMED
    FDA Recall Open, Classified

    iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002

    Recall: Z-1751-2022 · Initiated July 20, 2022

    Recall

    Recall Number
    Z-1751-2022
    Event Number
    90762
    Firm
    Alcor Scientific, Inc.
    FEI Number
    3003855297
    Product Code
    GKB
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 20, 2022
    Address
    20 Thurber Blvd, Smithfield, RI, 02917-1858

    Description

    iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002

    Reason

    Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube

    Action

    Alcor Scientific notified consignees via Emails on 21 July 2022 that included an Advisory Notice (AN-001). Letter states reason for recall, health risk and action to take: " Remove from your inventory any Lot 4/22 Primary Pump Tubing Spare Part Kits (112-13-002). Destroy this tubing. " If the tubing has been installed on any iSED ESR Analyzers, the tubing must be immediately replaced with new Primary Pump Tubing (112-13-002) from any other lot and Alcor must be notified of the locations where that tubing was installed. " Complete this form and return via email to [email protected] within 3 days. ALCOR will replace all Primary Pump Tubing from Lot 4/22 that was shipped to your facility.

    Distribution

    US Nationwide Distribution - FL, MA, MD, PA, SD, WI Foreign: Croatia Honduras Korea

    Quantity

    38 units