BEUDAMED
    FDA Enforcement Class II Ongoing

    Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

    Recall: Z-1407-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1407-2021
    Event ID
    87561
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 21, 2021
    Initiation Date
    March 15, 2021
    Classification Date
    April 9, 2021
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

    Reason

    Possible false negative or false positive results due to the product being compromised during shipment.

    Code Info

    Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000

    Distribution

    US Nationwide distribution in the state of Ohio.

    Quantity

    24 each