BEUDAMED
    FDA Enforcement Class II Ongoing

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    Recall: Z-2173-2024 · Reported July 3, 2024

    Enforcement

    Recall Number
    Z-2173-2024
    Event ID
    94678
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SIGHT DIAGNOSTICS LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2024
    Initiation Date
    May 13, 2024
    Classification Date
    June 21, 2024
    Address
    23, Derekh Menakhem Begin, Tel Aviv-Yafo, N/A, Israel

    Description

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    Reason

    One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.

    Code Info

    REF: TK1, UDI-DI: B787TK10, Lot Code: 10114

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.

    Quantity

    7,450 units (2,800 US, 4,650 OUS)